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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0450
In Commercial Distribution

  • 09348215057060 ()


  • Instrument tray, reusable
No Description
Cochlear Bone Anchored Solutions AB
95980
In Commercial Distribution

  • 09321502034661 ()
95980

  • Bone-conduction hearing implant system sound processor/vibrator
Tray/case used to hold other medical devices
ENZTEC LIMITED
LEC00120C
In Commercial Distribution

  • 09421028117180 ()
LEC00120C

  • Instrument tray, reusable
Sugita Titanium Clips II Case EB for Extra B
MIZUHO CORPORATION
17-010-08
In Commercial Distribution

  • 04946329214604 ()

  • Length: 8.86 Inch
17-010-08

  • Surgical clip rack
Sugita Titanium Clips II Case EA for Extra A
MIZUHO CORPORATION
17-010-07
In Commercial Distribution

  • 04946329214598 ()

  • Length: 8.86 Inch
17-010-07

  • Surgical clip rack
Sugita Titanium Clip II Case E for Standard, Fenestrated and Long Clips
MIZUHO CORPORATION
17-010-84
In Commercial Distribution

  • 04946329189629 ()

  • Length: 8.86 Inch
17-010-84

  • Surgical clip rack
Sugita Titanium Clip II Case D for Fenestrated Clips
MIZUHO CORPORATION
17-010-83
In Commercial Distribution

  • 04946329189612 ()

  • Length: 8.86 Inch
17-010-83

  • Surgical clip rack
Sugita Titanium Clip II Case C for Standard Clips
MIZUHO CORPORATION
17-010-82
In Commercial Distribution

  • 04946329189605 ()

  • Length: 8.86 Inch
17-010-82

  • Surgical clip rack
Sugita Titanium Clip II Case B for Mini, Temporary and Standard Clips
MIZUHO CORPORATION
17-010-81
In Commercial Distribution

  • 04946329189599 ()

  • Length: 8.86 Inch
17-010-81

  • Surgical clip rack
Sugita Titanium Clip II Case A for Appliers
MIZUHO CORPORATION
17-010-80
In Commercial Distribution

  • 04946329189582 ()

  • Length: 20.68 Inch
17-010-80

  • Instrument transport trolley system
No Description
KEELER LIMITED
1132-P-1157-500
In Commercial Distribution

  • 05055272719933 ()


  • Direct ophthalmoscope
No Description
KEELER LIMITED
1128-P-1014-500
In Commercial Distribution

  • 05055272719926 ()


  • Direct ophthalmoscope
No Description
KEELER LIMITED
1302-P-1011
In Commercial Distribution

  • 05055272701600 ()


  • Retinoscope, line-powered
No Description
KEELER LIMITED
1128-P-1014
In Commercial Distribution

  • 05055272700788 ()


  • Direct ophthalmoscope
No Description
KEELER LIMITED
1128-P-1013
In Commercial Distribution

  • 05055272700771 ()


  • Direct ophthalmoscope
No Description
KEELER LIMITED
1302-P-1010
In Commercial Distribution

  • 05055272701594 ()


  • Retinoscope, line-powered
No Description
KEELER LIMITED
1302-P-1009
In Commercial Distribution

  • 05055272701587 ()


  • Retinoscope, line-powered
No Description
KEELER LIMITED
1302-P-1008
In Commercial Distribution

  • 05055272701570 ()


  • Retinoscope, line-powered
No Description
KEELER LIMITED
1132-P-1157
In Commercial Distribution

  • 05055272700900 ()


  • Indirect binocular ophthalmoscope
No Description
KEELER LIMITED
1132-P-1149
In Commercial Distribution

  • 05055272700894 ()


  • Direct ophthalmoscope, line-powered
No Description
FLEXICARE MEDICAL LIMITED
032-10-036U
In Commercial Distribution

  • 05055931102052 ()


  • Benchtop nebulizer, non-heated
No Description
PRO-DEX, INC.
APD-SC-001
In Commercial Distribution

  • 00860540000294 ()


  • Device sterilization/disinfection container, reusable
Sterilzation Wire Basket for STar(TM) Drive System
FHC, INC.
67-00-7-00299
In Commercial Distribution

  • 00873263002995 ()
67-00-7

  • Neurosurgical micro targeting drive
An adhesive substance designed to assist patients with retaining their stockings in the prescribed location.
SIGVARIS INC
581I
In Commercial Distribution

  • 00745129164713 ()

  • No Device Sizes
581I300

  • Compression/pressure sock/stocking, single-use
No Description
ALIMED, INC.
71125520
In Commercial Distribution

  • 00733657286076 ()
  • 00733657300307 ()
2970008724

  • Bedpan
No Description
Respironics Novametrix, LLC
00
In Commercial Distribution

  • 30884838075581 ()
  • 00884838075580 ()
8-100337-00

  • Home CPAP unit
No Description
Biomet Orthopedics, LLC
592215
In Commercial Distribution

  • 00880304395527 ()
592215

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595604
In Commercial Distribution

  • 00880304468467 ()
595604

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595609
In Commercial Distribution

  • 00880304468443 ()
595609

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595603
In Commercial Distribution

  • 00880304468436 ()
595603

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595602
In Commercial Distribution

  • 00880304463097 ()
595602

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
110010236
In Commercial Distribution

  • 00880304568631 ()
110010236

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
110002769
In Commercial Distribution

  • 00880304566545 ()
110002769

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
591429
In Commercial Distribution

  • 00880304675308 ()
591429

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
591423
In Commercial Distribution

  • 00880304675087 ()
591423

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
591422
In Commercial Distribution

  • 00880304675070 ()
591422

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
591404
In Commercial Distribution

  • 00880304675049 ()
591404

  • Instrument tray, reusable
SWAT-T Stretch-Wrap and Tuck Tourniquet A Proven Multi-function Life Saving First Aid Device
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M689SWATTORGCA010 ()
SWAT-T ORG-CA

  • Tourniquet cuff, single-use
SWAT-T Stretch-Wrap and Tuck A Proven Multi-function Tourniquet & Trauma Care Device
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M689SWATTBLKCA010 ()
SWAT-T BLK-CA

  • Tourniquet cuff, single-use
SWAT-T Stretch-Wrap and Tuck Tourniquet A Proven Multi-function Life Saving First Aid Device
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M689SWATTORG010 ()
SWAT-T ORG

  • Tourniquet cuff, single-use
Audio Processor Telecoil Adapter
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
39486
In Commercial Distribution

  • 09008737394868 ()


  • Hearing aid/implant system functionality-enhancing device
Middle Kit
Megagen Implant Co. Ltd
KAGIN2002
In Commercial Distribution

  • 08809728993869 ()
KAGIN2002

  • Fixture/appliance dental drill bit, reusable
No Description
Zimmer, Inc.
SSI007580
In Commercial Distribution

  • 00889024675322 ()
SSI007580

  • Instrument tray, reusable
No Description
Zimmer, Inc.
SSI007555
In Commercial Distribution

  • 00889024670907 ()
SSI007555

  • Instrument tray, reusable
Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system
No Description
Zimmer, Inc.
20-8060-306-00
In Commercial Distribution

  • 00889024618947 ()
20-8060-306-00

  • Device sterilization/disinfection container, reusable
No Description
BioGenetics CO.,LTD.
Plain
In Commercial Distribution

  • 08802550012227 ()
  • 08802550012012 ()


  • Basic male condom, Hevea-latex
A reusable instrument storage case that can house and retain the reusable instruments of the Removal Tool Set during sterilization processing in preparation for Implant removal.
Curvafix Inc
CIC-005
In Commercial Distribution

  • 10855068008836 ()
CIC-005

  • Device sterilization/disinfection container, reusable
Reusable, stainless steel instrument storage case that is used to contain the implant selection device during sterilization processing in preparation for pelvic fixation procedure.
Curvafix Inc
CIC-002
In Commercial Distribution

  • 10855068008355 ()
CIC-002

  • Device sterilization/disinfection container, reusable
No Description
FEETME
V4
In Commercial Distribution



  • Noninvasive device battery charger
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