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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Needle Holder, 5mm with TC inserts with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8516-04-R
In Commercial Distribution

  • 00848657004671 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
SonoMSK 22G x 150mm with Cornerstones, with Stylet,
Pajunk GmbH Medizintechnologie
1191-4E150
Not in Commercial Distribution

  • 14048223033101 ()
  • 04048223033104 ()
1191-4E150

  • Peripheral nerve-block sharp needle
SonoMSK 22G x 25mm with Cornerstones, with Stylet,
Pajunk GmbH Medizintechnologie
1191-4E025
Not in Commercial Distribution

  • 14048223033095 ()
  • 04048223033098 ()
1191-4E025

  • Peripheral nerve-block sharp needle
SonoMSK 22G x 120mm with Cornerstones, with Stylet,
Pajunk GmbH Medizintechnologie
1191-4E120
Not in Commercial Distribution

  • 14048223033057 ()
  • 04048223033050 ()
1191-4E120

  • Peripheral nerve-block sharp needle
SonoMSK 22G x 90mm with Cornerstones, with Stylet,
Pajunk GmbH Medizintechnologie
1191-4E090
Not in Commercial Distribution

  • 14048223033040 ()
  • 04048223033043 ()
1191-4E090

  • Peripheral nerve-block sharp needle
SonoMSK 22G x 70mm with Cornerstones, with Stylet,
Pajunk GmbH Medizintechnologie
1191-4E070
Not in Commercial Distribution

  • 14048223033033 ()
  • 04048223033036 ()
1191-4E070

  • Peripheral nerve-block sharp needle
Men's Liberty Acute Compatible with Suction with CathGrip
ARGENTUM MEDICAL, LLC
2102616
In Commercial Distribution

  • 10653599001957 ()
  • 00653599001950 ()


  • Urinary incontinence penis sheath/port, single-use
Grasper, 5mm with spoon, pointed version with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-26-R
In Commercial Distribution

  • 00848657002936 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Biopsy Punch, 5mm with tooth, 26cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8517-02-26-R
In Commercial Distribution

  • 00848657001250 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Biopsy Punch, 5mm with tooth, 45cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8517-02-45-R
In Commercial Distribution

  • 00848657001243 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Tempus Pro Rainbow - with Capnometry & with BT Dock
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1007-R
In Commercial Distribution

867421

  • Multiple vital physiological parameter monitoring system, clinical
Tempus Pro Rainbow - with Capnometry & with BT Dock
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1007-R
Not in Commercial Distribution

  • 05060472440013 ()


  • Multiple vital physiological parameter monitoring system, clinical
with extra reservoir bag, with B/V filter
WESTMED, INC.
0336
In Commercial Distribution

  • 10709078000727 ()
  • 00709078000720 ()


  • Heat/moisture exchanger/microbial medical gas filter
  • Nebulizing system delivery set, single-use
Monitor with DOX SPO2, NIBP, HR with Bluetooth
CRITICARE TECHNOLOGIES, INC.
eQuality 506DNB
In Commercial Distribution

  • D438506DNBUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical
bayonet with screws, serrated with thorns, 15.5 cm
Spiggle & Theis Medizintechnik GmbH
20-720-14
In Commercial Distribution

  • 04250381855744 ()
20-720-14

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
with Lok-Bar™ for use with Canon Orian
MEDTEC, INC.
MTM6508
In Commercial Distribution

  • 00841439112762 ()

  • Width: 609 Millimeter
  • Length: 2011 Millimeter
MTM6508

  • Indexed-immobilization patient positioning system
THERMOPLASTIC INSTRUMENT TRAY WITH MAT & LID WITH CLASPS
SONTEC INSTRUMENTS, INC.
18-3240
Not in Commercial Distribution

  • 00192896099159 ()

  • Height: 4.5 Inch
  • Width: 10 Inch
  • Length: 15 Inch
18-3240

  • Instrument tray, reusable
Passer, Chest-Tube 24cm with catch with guide bracket
Geister Medizintechnik GmbH
03-7601
In Commercial Distribution

  • 04057034015360 ()
03-7601

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
"HighLite" with comfortable headband transformer & charger, with mobile
Spiggle & Theis Medizintechnik GmbH
10-122-00
In Commercial Distribution

  • 04053755180318 ()
10-122-00

  • Head-worn fibreoptic light
ELVAREX 1/GLOVE/WITH FINGER, WITH THUMB/NAVY
BSN-Jobst GmbH
77325-00040-00
In Commercial Distribution

  • 04059993105021 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/GLOVE/WITH FINGER, WITH THUMB/NAVY
BSN-Jobst GmbH
77558-00052-00
In Commercial Distribution

  • 04059993101856 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/GLOVE/WITH FINGER, WITH THUMB/CHERRY
BSN-Jobst GmbH
77325-00056-00
In Commercial Distribution

  • 04059993082131 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/GLOVE/WITH FINGER, WITH THUMB/CHERRY
BSN-Jobst GmbH
77558-00068-00
In Commercial Distribution

  • 04059993063734 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Smart Outlet with bed pad with remote reset
Smart Caregiver Corporation
433SBW1-SYS
In Commercial Distribution

  • 00812293013779 ()


  • Bed/chair occupant movement pressure/vibration sensor
Smart Outlet with bed pad with remote reset
Smart Caregiver Corporation
433SBR1-SYS
In Commercial Distribution

  • 00812293011959 ()


  • Bed/chair occupant movement pressure/vibration sensor
Spare-tube, with 22 mm adapter, with clamp below
Tracoe medical GmbH
REF 888-107-07IK-2
Not in Commercial Distribution

  • 04035324031764 ()

  • Lumen/Inner Diameter: 5.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Laparoscopy / Pelviscopy Drape with Underleg Wings with Adhesive
O&M HALYARD, INC.
41379
In Commercial Distribution

  • 30680651413797 ()
  • 90680651413799 ()
41379NS

  • Patient surgical drape, single-use
#0 Ring Pessary with Incontinence Knob with Support
MARINA MEDICAL INSTRUMENTS, INC.
BRK1.75S
In Commercial Distribution

  • 00840306821172 ()
BRK1.75S

  • Pelvic-organ-supporting pessary
St Marks Retractor With Light, 11in With Lip
MARINA MEDICAL INSTRUMENTS, INC.
120-584L
In Commercial Distribution

  • 00840306819759 ()

  • Length: 11 Inch
120-584L

  • Vascular dilator, reusable
Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
In Commercial Distribution

  • 00757770520251 ()
BL14304

  • Phacoemulsification/vitrectomy system
Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
Not in Commercial Distribution

  • 00757770519897 ()
BL14304

  • Phacoemulsification/vitrectomy system
Vented IV Set with 72" Line with Chamber
ARGON MEDICAL DEVICES, INC.
039830000A
Not in Commercial Distribution

  • 20886333200775 ()
  • 00886333200771 ()

  • 72"
039830000A

  • Fluid transfer set, general-purpose
DreamStation BiPAP Pro with Humidifier and Cellular, USA
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with Cell, US
In Commercial Distribution

  • 00606959025660 ()
DSX600H11C

  • Home BPAP unit
DreamStation BiPAP Pro with Humidifier and Cellular Modem, American Home Patient (AHP)
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with Cell, AHP
Not in Commercial Distribution

  • 00606959025516 ()
AHX600H11C

  • Home BPAP unit
AF541 Mask with Standard Elbow, with 4 Point Headgear, Extra Large
Respironics, Inc.
AF541 Mask with SE, WITH 4-PT HEADGEAR, X-LARGE
In Commercial Distribution

  • 30606959024633 ()
  • 00606959024632 ()
1121077

  • CPAP/BPAP face mask, single-use
AF541 Mask with Standard Elbow, with 4 Point Headgear, Medium
Respironics, Inc.
AF541 Mask with SE, WITH 4-PT HEADGEAR, MEDIUM
In Commercial Distribution

  • 30606959024619 ()
  • 00606959024618 ()
1121075

  • CPAP/BPAP face mask, single-use
DreamStation BiPAP Pro with Humidifier and WiFi, American Home Patient
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with WiFi, AHP
Not in Commercial Distribution

  • 00606959034297 ()
AHX600H11W

  • Home BPAP unit
AF541 Mask with Standard Elbow, with 4 Point Headgear, Large
Respironics, Inc.
AF541 Mask with SE, WITH 4-PT HEADGEAR, LARGE
In Commercial Distribution

  • 30606959024626 ()
  • 00606959024625 ()
1121076

  • CPAP/BPAP face mask, single-use
AF541 Mask with Standard Elbow, with 4 Point Headgear, Small
Respironics, Inc.
AF541 Mask with SE, WITH 4-PT HEADGEAR, SMALL
In Commercial Distribution

  • 30606959024602 ()
  • 00606959024601 ()
1121074

  • CPAP/BPAP face mask, single-use
FitLife Mask with Standard Elbow, with Headgear, Extra Large, Japan
Respironics, Inc.
FitLife Mask with SE, with Headgear, XLarge, JP
Not in Commercial Distribution

  • 00606959023109 ()
1089997

  • CPAP/BPAP face mask, reusable
FitLife Mask with Standard Elbow, with Headgear, Extra Large, International
Respironics, Inc.
FitLife Mask with SE, with Headgear, XLarge, INTL
In Commercial Distribution

  • 00606959023079 ()
1089995

  • CPAP/BPAP face mask, reusable
AF541 Mask with Standard Elbow with Capstrap, Size Large, Japan
Respironics, Inc.
AF541 Mask with SE, with Capstrap, Large, JP
Not in Commercial Distribution

  • 30606959041371 ()
  • 00606959041370 ()
1129506

  • CPAP/BPAP face mask, single-use
AF541 Mask with Standard Elbow with Capstrap, Size Medium, Japan
Respironics, Inc.
AF541 Mask with SE, with Capstrap, Medium, JP
Not in Commercial Distribution

  • 30606959041364 ()
  • 00606959041363 ()
1129505

  • CPAP/BPAP face mask, single-use
Elvarex 2/Arm sleeve to axilla with glove, one piece/With Finger, with Thumb
BSN-Jobst GmbH
77360-00004-00
In Commercial Distribution

  • 04019702339000 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/GLOVE TO ELBOW/WITH FINGER, WITH THUMB/SLIP FORM WITH VOLANT/BLACK
BSN-Jobst GmbH
77359-00017-00
In Commercial Distribution

  • 04019702303001 ()

  • Pressure 23-32 mmHg
77359-00017-00

  • Compression/pressure sock/stocking, reusable
ELVAREX 2/GLOVE TO ELBOW/WITH FINGER, WITH THUMB/SLIP FORM WITH VOLANT/CARAMEL
BSN-Jobst GmbH
77359-00043-00
In Commercial Distribution

  • 04019702302745 ()

  • Pressure 23-32 mmHg
77359-00043-00

  • Compression/pressure sock/stocking, reusable
Elvarex 2/Glove to elbow/With Finger, with Thumb/Slip form with volant/Honey
BSN-Jobst GmbH
77359-00125-00
In Commercial Distribution

  • 04019702529340 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
5mm 45cm Maryland Dissector, with Diamond Serrations with with Non- Locking Reinforced, Carbon Fiber
Surgical Direct, Inc.
SD14128-53
In Commercial Distribution

  • B382SD14128530 ()
SD14128-53

  • Flexible endoscopic tissue manipulation forceps, single-use
Closed Suction Catheter, 10Fr, Elbow Tracheostomy, 24 Hour, with Caps, with 22mm Flex Adapter, with HME adapter, with Trach Wedge
Twin Med, LLC
1005592
In Commercial Distribution

  • 30840330703483 ()
  • 10840330703489 ()
  • 50840330703487 ()
  • 70840330703481 ()

  • Catheter Gauge: 10 French
  • Catheter Inner Diameter: 3.3 Millimeter
  • Length: 40.5 Centimeter
1005592

  • Airway suction catheter
Closed Suction Catheter, 8Fr, Elbow Tracheostomy, 24 Hour, with Caps, with 22mm Flex Adapter, with HME adapter, with Trach Wedge
Twin Med, LLC
1005591
In Commercial Distribution

  • 30840330703476 ()
  • 10840330703472 ()
  • 50840330703470 ()
  • 70840330703474 ()

  • Catheter Gauge: 8 French
  • Catheter Inner Diameter: 2.6 Millimeter
  • Length: 30.5 Centimeter
1005591

  • Airway suction catheter
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