Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Welch Allyn Green Series 777 Integrated Wall Diagnostic System including SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066760 ()
77791-MXNOBP

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (# 11720), MacroView Otoscope with Throat Illuminator (#23820), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066265 ()
77796-M

  • Aneroid manual sphygmomanometer
The Latitude Style Foot Platform assembly is designed for use with Motion Concepts Power Elevating Calf Panel. The latitude-style foot platform is available with an optional padded foam cover (in standard black Polyester fabric or Onyx (faux-vinyl) fabric), or may be order without a pad.
Motion Concepts Inc
D-0197-LSF
In Commercial Distribution

  • 07540147002299 ()
LSF

  • Wheelchair footrest/legrest
Planmeca Compact i is a dental operative unit including a dental patient chair. The unit is equipped with a digital control system and a user interface which is either a touch panel or a traditional keyboard. The instrument console includes five instrument locations, with easy instrument change.
Planmeca Oy
i
In Commercial Distribution

  • 06430035420438 ()
10031950, 10031951, 10031952, 10031953, 10039745, 10031954, 10031955

  • Dental delivery system
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope (#11810), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC P
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094067019 ()
77791-1MPX

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Pl
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066807 ()
77791-MX

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (40 x 12 in / 101.6 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC P
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094121315 ()
77781-MX

  • Aneroid manual sphygmomanometer
The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples.
Luminex Molecular Diagnostics, Inc
I046B0427
In Commercial Distribution

  • 00840487100172 ()
I046B0427

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope with LED (#11720-L), MacroView Otoscope with LED (#23810-L), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094201796 ()
77792-ML

  • Noninvasive device battery charger
NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol Candida/TV Positive Control is a qualitative control containing intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
ZEPTOMETRIX CORPORATION
NATtrol™ Candida/TV Positive Control
Not in Commercial Distribution

  • 01220000260252 ()
NATCTVPOS-BD

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Panther Fusion® Extraction Reagents-S.
Hologic, Inc.
KIT, EXTRACTION REAGENTS - S, FUSION, IVD
In Commercial Distribution

  • 15420045509214 ()
PRD-04331

  • Nucleic acid technique (NAT) kit IVD
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066715 ()
77792-2MP

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Mounting Screws for Spot Lxi Vital Signs Device (order device separately), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 10
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094066487 ()
77794-2MPLXI

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Mounting Screws for Spot Lxi Vital Signs Device (order device separately), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066456 ()
77794-MLXI

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Mounting Screws for Spot Vital Signs Device (order device separately), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066432 ()
77794-MSPOT

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), Pneumatic Otoscope (#20201), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066043 ()
77797-X

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (40 x 12 in / 101.6 x 30.5 cm), Short Power Cord (18 in/45.7 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094121292 ()
77782-16M

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Mounting Screws for Spot Vital Signs Device (order device separately), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-24
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094121254 ()
77794-2MPSPOT

  • Aneroid manual sphygmomanometer
The "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells. They may also be used with 14x17” film or CR cassettes. They house an x-ray grid to be used in general radiography. Their secondary purpose is to hold a DR Panel during exams. "
Reina Imaging
P[2][X]DR[NG][Y]
In Commercial Distribution

  • 00860001700183 ()
Premium Grid Encasement

  • Stationary x-ray grid
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259605 ()
XSCRIBE-6CC-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094307085 ()
XSCRIBE-6DC-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope with Throat Illuminator (#23820), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066401 ()
77795-MX

  • Aneroid manual sphygmomanometer
The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel.
SMART MEDICAL SYSTEMS LTD
SPARKC
In Commercial Distribution

  • 07290018671504 ()
40-016

  • Catheter/overtube balloon inflator, reusable
NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
ZEPTOMETRIX CORPORATION
NATtrol™ BV Positive Control
Not in Commercial Distribution

  • 01220000260238 ()
NATBVPOS-BD

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens with LED (#11820-L), MacroView Otoscope with LED (#23810-L), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094201802 ()
77792-2MPL

  • Aneroid manual sphygmomanometer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; No printer, basic laser transport cart with base and back panel; AHA 10 wire, 12- lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259780 ()
XSCRIBE-6CC-CEAAX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259636 ()
XSCRIBE-6CC-DEBAX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259612 ()
XSCRIBE-6CC-DEBXB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259407 ()
XSCRIBE-6DC-DEBAX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259162 ()
XSCRIBE-6GC-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Connex ProBP 3400 Digital Blood Pressure Device with SureBP (#34XFWT-B), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066746 ()
77791-MXPROBP

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Mercury Tri Test Blood Metal Panel Sample Collection Kit • 4 sample labels • 2 absorbent cloths • 2 biohazard zip-top specimen bags • 2 blood collection tubes • 1 urine collection tube • 1 urine collection cup • 1 hair collection bag • 1 Quicksilver sample box for shipping • Patient requisition form • 1 laboratory shipping pak • 1 Prepaid 2-Day Air Shipping Label
Quicksilver Scientific, Inc.
1
In Commercial Distribution

  • 00810147500260 ()


  • Drug-testing specimen collection kit IVD
Q Switched Nd: YAG Laser machine (QNHF-01) is laser system which delivers las:er at a wavelength 1064nm or 532nm. It consists of control panelmodule, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel
Beijing Nubway S&T Co., Ltd.
QNHF-01
In Commercial Distribution

  • 06971679500914 ()


  • Dermatological laser beam guiding handpiece
The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 XS
In Commercial Distribution

  • 05391512285791 ()
  • 05391512281458 ()
584

  • Lumbar spine orthosis
The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 4XL
In Commercial Distribution

  • 05391512285869 ()
  • 05391512281120 ()
584

  • Lumbar spine orthosis
The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 3XL
In Commercial Distribution

  • 05391512285852 ()
  • 05391512281113 ()
584

  • Lumbar spine orthosis
The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 XXL
In Commercial Distribution

  • 05391512281106 ()
  • 05391512285845 ()
584

  • Lumbar spine orthosis
The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 XL
In Commercial Distribution

  • 05391512285838 ()
  • 05391512281090 ()
584

  • Lumbar spine orthosis
The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 L
In Commercial Distribution

  • 05391512285821 ()
  • 05391512281083 ()
584

  • Lumbar spine orthosis
The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 M
In Commercial Distribution

  • 05391512285814 ()
  • 05391512281076 ()
584

  • Lumbar spine orthosis
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