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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The Spectrum infusion pump consists of electronic circuitry and mechanisms in a plastic enclosure. The operation is software controlled, with linear peristaltic pumping design. The Spectrum is designed for the application of standard gravity infusion sets as indicated by the Spectrums labeling.
BAXTER INTERNATIONAL INC.
35700BAX
In Commercial Distribution

  • 00085412091570 ()
35700BAX

  • Bedside infusion pump, single-channel
Hayrake-Palatal with Spurs
ALLESEE AOA-PRO
3000-0073
In Commercial Distribution

  • 00889989083545 ()


  • Orthodontic habit prevention/breaking appliance, bonded
Adhesive Bandages, scary designs, 3/4 IN x 3 IN (19 mm x 76 mm)
Aso LLC
017276238822
In Commercial Distribution

  • 60017276238824 ()
  • 00017276238822 ()


  • Skin-cover adhesive strip, non-antimicrobial
30cm Cannula with Guide
ATRICURE, INC.
CSK-6131
In Commercial Distribution

  • 10840143901607 ()
  • 30840143901670 ()
  • 50840143900110 ()

  • Length: 30 Centimeter
A001311

  • Cardiac radio-frequency ablation system generator
Alif Drill with Handle (Pre-Drill)
KOROS U.S.A., INC.
7332-54
In Commercial Distribution

  • 00840199515981 ()
  • 10840199515988 ()
7332-54

  • Surgical drill guide, reusable
No Description
implantcast GmbH
42240135
In Commercial Distribution

  • 04048844402334 ()

  • 2.5mm


  • Medullary canal orthopaedic reamer, rigid
Probe With Eye Stainless Steel
SONTEC INSTRUMENTS, INC.
197-666
In Commercial Distribution

  • 00192896110076 ()

  • Length: 9 Inch


  • Gastro-urological director
Osteotome With Guide Straight 3 Millimeters
SONTEC INSTRUMENTS, INC.
475-785G2
In Commercial Distribution

  • 00192896108929 ()

  • Length: 7.25 Inch


  • Plastic surgery osteotome
Tray With Brackets Stainless Steel
SONTEC INSTRUMENTS, INC.
18-2001
In Commercial Distribution

  • 00192896121072 ()

  • Height: 14 Millimeter
  • Length: 400 Millimeter
  • Width: 250 Millimeter
18-2001

  • Instrument tray, reusable
Probe With Eye Stainless
SONTEC INSTRUMENTS, INC.
197-662
In Commercial Distribution

  • 00192896116252 ()

  • Length: 5.5 Inch
197-662

  • Gastro-urological director
INSERT WITH MAT
SONTEC INSTRUMENTS, INC.
1103-7171
In Commercial Distribution

  • 00192896019430 ()

  • Length: 11 Inch
  • Height: 1.5 Inch
  • Width: 7 Inch
1103-7171

  • Instrument tray, reusable
Dental cartridge syringe
SEPTODONT, INC
01N2030
In Commercial Distribution

  • 00303620000017 ()

  • Total Volume: 1.8 Milliliter
01N2030

  • Syringe-loaded medication/vaccine injector, manual, professional
No Description
CME AMERICA LLC
100-743XI
Not in Commercial Distribution

  • B101100743XI0 ()


  • Bedside infusion pump, single-channel
No Description
ELECTRO-CAP INTERNATIONAL INC
E2S-22WIRE
In Commercial Distribution

  • 00811478011739 ()
E2S-22WIRE

  • Analytical scalp lead
No Description
ELECTRO-CAP INTERNATIONAL INC
E2S
In Commercial Distribution

  • 00811478011593 ()
E2S

  • Analytical scalp lead
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size 2 x 2800 ml
Xvivo Perfusion AB
19018
Not in Commercial Distribution

  • 07350069520067 ()
19018

  • Donor-organ/tissue/cell preservation solution
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 8x 1000 ml
Xvivo Perfusion AB
19017
Not in Commercial Distribution

  • 07350069520050 ()
19017

  • Donor-organ/tissue/cell preservation solution
No Description
Biomet Orthopedics, LLC
25-012
In Commercial Distribution

  • 00887868074127 ()
25012

  • Bone tap, reusable
disposable CPR faceshield with one way valve and filter
B.L.S. Systems Limited
3000
In Commercial Distribution

  • B00230007 ()
  • B00230000 ()
3000

  • Cardiopulmonary resuscitation mask, single-use
AnchorSeed/TSL in FlatPack – 15 stranded seeds per mag– STERILE
THERAGENICS CORPORATION
XX77315iF
In Commercial Distribution

  • 00813787021331 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed/TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77315iN
In Commercial Distribution

  • 00813787021324 ()


  • Manual brachytherapy source, permanent implant
VariStrand with OncoSeed, x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
ON772xi
In Commercial Distribution

  • 00813787021232 ()


  • Manual brachytherapy source, permanent implant
VariStrand with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX772xi
In Commercial Distribution

  • 00813787021171 ()


  • Manual brachytherapy source, permanent implant
AnchorLoad with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX782xi
In Commercial Distribution

  • 00813787021157 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed in Flatpack – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iF
In Commercial Distribution

  • 00813787021133 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iN
In Commercial Distribution

  • 00813787021119 ()


  • Manual brachytherapy source, permanent implant
ConnectWeb viewer front-end with PACSCore back-end archive
Radius
3
In Commercial Distribution

  • B295FULLPACS30 ()


  • Radiological PACS software
The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002517 ()
  • 00896241002510 ()
  • 20896241002514 ()


  • Microbial water purification filter, non-sterilizable
The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002500 ()
  • 00896241002503 ()


  • Microbial water purification filter, non-sterilizable
No Description
Octostop Inc
FI-01A
In Commercial Distribution

  • B525FI01A0 ()


  • X-ray/radiation therapy beam filter, wedge
The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.
VORTRAN MEDICAL TECHNOLOGY 1, INC
IPM-4022
In Commercial Distribution

  • 20637320040221 ()
  • 10637320040224 ()
IPM-4022

  • Ultrasonic nebulizing system
The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
MRIAUDIO, INC.
3501
In Commercial Distribution

  • B66935011 ()
3501

  • Patient audiovisual communication/entertainment system
The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
MRIAUDIO, INC.
3500
In Commercial Distribution

  • B66935001 ()
3500

  • Patient audiovisual communication/entertainment system
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
1000 ml
In Commercial Distribution

  • B502BSB01680 ()
BSB 0168

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
500 ml
In Commercial Distribution

  • B502BSB01670 ()
BSB 0167

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
200 ml
In Commercial Distribution

  • B502BSB01660 ()
BSB 0166

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
100 ml
In Commercial Distribution

  • B502BSB01650 ()
BSB 0165

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
50 ml
In Commercial Distribution

  • B502BSB01640 ()
BSB 0164

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
15 ml
In Commercial Distribution

  • B502BSB01630 ()
BSB 0163

  • DAPI solution IVD
Driver with Sleeve
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
F003.0018
In Commercial Distribution

  • B922F00300180 ()
F003.0018

  • Surgical screwdriver, reusable
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