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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APEX Degenerative Implants Case -Case and Lid Only-
SPINECRAFT, LLC
6000-310B
In Commercial Distribution

  • 00193082051579 ()
6000-310B

  • General internal orthopaedic fixation system implantation kit
Karlin Case, Lumbar Microdiscectomy Biopsy, (Case for 12)
SYMMETRY SURGICAL INC.
46-3145
In Commercial Distribution

  • 00887482014622 ()
46-3145

  • Instrument tray, reusable
ONE Oasis 4.5 ml case- Case of 1000
GLOBAL PROTECTION CORP.
11L102C
In Commercial Distribution

  • 80726893210222 ()
  • 20726893210220 ()


  • Sexual lubricant
7/POUCH, 100 POUCHES/CASE, 700 PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
P10072-7NB
In Commercial Distribution

  • 30813150021914 ()
  • 00813150021913 ()
P10072-7NB

  • Electrocardiographic electrode, single-use
CASE 8889260 TSRH SILO MAS OUTER CASE TI
MEDTRONIC SOFAMOR DANEK, INC.
8889260
In Commercial Distribution

  • 00885074494036 ()


  • Instrument tray, reusable
CASE 8889220 TSRH SILO HK OUTER CASE TI
MEDTRONIC SOFAMOR DANEK, INC.
8889220
In Commercial Distribution

  • 00885074493985 ()


  • Instrument tray, reusable
CASE 8889203 TSRH SILO INST OUTER CASE 3
MEDTRONIC SOFAMOR DANEK, INC.
8889203
In Commercial Distribution

  • 00885074493978 ()


  • Instrument tray, reusable
CASE 8889202 TSRH SILO INST OUTER CASE 2
MEDTRONIC SOFAMOR DANEK, INC.
8889202
In Commercial Distribution

  • 00885074493961 ()


  • Instrument tray, reusable
CASE 8889201 TSRH SILO INST OUTER CASE 1
MEDTRONIC SOFAMOR DANEK, INC.
8889201
In Commercial Distribution

  • 00885074493954 ()


  • Instrument tray, reusable
Storage case for Flat Panel Senser
FUJIFILM CORPORATION
DR600 SE CASE E
In Commercial Distribution

  • 04547410134667 ()


  • Stationary basic diagnostic x-ray system, digital
Storage case for Flat Panel Senser
FUJIFILM CORPORATION
DR602 SE CASE E
In Commercial Distribution

  • 04547410193565 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CardioTek B.V.
08ACC01
In Commercial Distribution

  • 04260441450574 ()


  • Cardiac electrophysiology analysis system
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9974-000
In Commercial Distribution

  • 00848665039283 ()


  • Surgical instrument/implant rack
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9911
In Commercial Distribution

  • 00848665024043 ()


  • Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-501
In Commercial Distribution

  • 09348215040420 ()


  • Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-601
In Commercial Distribution

  • 09348215040178 ()


  • Instrument tray, reusable
No Description
KaVo Dental GmbH
1.009.5746
In Commercial Distribution

  • EKAV100957460 ()
619460C

  • Dental power tool system handpiece, pneumatic
Case 2 Complete
SYMMETRY MEDICAL INC.
87-1178
In Commercial Distribution

  • 00847538019124 ()
2500-00-794

  • Device sterilization/disinfection container, reusable
Case 1 Complete
SYMMETRY MEDICAL INC.
87-1164
In Commercial Distribution

  • 00847538019117 ()
2500-00-793

  • Device sterilization/disinfection container, reusable
Sugita Clip Case E for Deflected Fenestrated, Large, Long and Booster Clips
MIZUHO CORPORATION
07-936-64
In Commercial Distribution

  • 04946329206517 ()

  • Length: 8.86 Inch
07-936-64

  • Surgical clip rack
Sugita Clip Case D for Fenestrated Large Clips
MIZUHO CORPORATION
07-936-63
In Commercial Distribution

  • 04946329206500 ()

  • Length: 8.86 Inch
07-936-63

  • Surgical clip rack
Sugita Clip Case C for Large Clips
MIZUHO CORPORATION
07-936-62
In Commercial Distribution

  • 04946329206494 ()

  • Length: 8.86 Inch
07-936-62

  • Surgical clip rack
Sugita Clip Case B for Mini, Standard and Temporary Clips
MIZUHO CORPORATION
07-936-61
In Commercial Distribution

  • 04946329206487 ()

  • Length: 8.86 Inch
07-936-61

  • Surgical clip rack
Sugita Clip Case A for Appliers
MIZUHO CORPORATION
07-936-60
In Commercial Distribution

  • 04946329206470 ()

  • Length: 20.60 Inch
07-936-60

  • Instrument transport trolley system
No Description
PRO-DEX, INC.
60.000.010
In Commercial Distribution

  • 00860540000201 ()
  • 10860540000208 ()


  • Device sterilization/disinfection container, reusable
No Description
Biomet Orthopedics, LLC
450072
In Commercial Distribution

  • 00880304377806 ()
450072

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
430100
In Commercial Distribution

  • 00880304375970 ()
430100

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595183
In Commercial Distribution

  • 00880304397422 ()
595183

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595182
In Commercial Distribution

  • 00880304397415 ()
595182

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595181
In Commercial Distribution

  • 00880304397408 ()
595181

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595180
In Commercial Distribution

  • 00880304397392 ()
595180

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595179
In Commercial Distribution

  • 00880304397385 ()
595179

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595016
In Commercial Distribution

  • 00880304396135 ()
595016

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
592112
In Commercial Distribution

  • 00880304394957 ()
592112

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
922170
In Commercial Distribution

  • 00880304480056 ()
922170

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595535
In Commercial Distribution

  • 00880304537699 ()
595535

  • Instrument tray, reusable
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500237 ()


  • Head-worn lamp
Dental Implant Surgical Instrument - KIT Bone Tack Case
Ossvis Co., Ltd.
HSBTC
In Commercial Distribution

  • 08809918249844 ()


  • Instrument tray, reusable
Audio Processor AudioStream Adapter
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
44786
In Commercial Distribution

  • 09008737447861 ()


  • Hearing aid/implant system functionality-enhancing device
No Description
Megagen Implant Co. Ltd
ARPK2000
In Commercial Distribution

  • 08806388285969 ()
ARPK2000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Megagen Implant Co. Ltd
KAGUN2000
In Commercial Distribution

  • 08806388255818 ()
KAGUN2000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Maxillofacial
Megagen Implant Co. Ltd
KMXIS2000
In Commercial Distribution

  • 08809708752509 ()
KMXIS2000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
BLUEDIAMOND Implant System
Megagen Implant Co. Ltd
KARO2003
In Commercial Distribution

  • 08809708752486 ()
KARO2003

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Carry Case, Universal, Activox
RESMED ASIA PTE. LTD.
123-102
Not in Commercial Distribution

  • 09353645000081 ()


  • Personal device holder, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-592-409
In Commercial Distribution

  • 09348215134921 ()


  • Instrument tray, reusable
Common
Megagen Implant Co. Ltd
AMOTSK2000
In Commercial Distribution

  • 08806388208241 ()
AMOTSK2000

  • Dental implant/prosthesis surgical procedure kit
Delfi’s PTS Transport Bag and Transport Case are custom designed to hold a single or twin PTS for BFR System including accessories and cuffs. The light and rugged cases are optimized for transport and storage of Delfi’s PTS Personalized Tourniquet Systems, making it the ideal solution for clinicians on the move.
Delfi Medical Innovations Inc
9-2200-410
In Commercial Distribution

  • M995922004101 ()


  • Surgical pneumatic tourniquet system
No Description
THINK SURGICAL, INC.
109939
In Commercial Distribution

  • M9461099390 ()
109939

  • Stereotactic system application software
Case 2 Complete
Tecomet
2500-00-794
In Commercial Distribution

  • 00817766026461 ()


  • Device sterilization/disinfection container, reusable
Poly-Tissue Pillow Case
MEDSOURCE INTERNATIONAL LLC
MS-44125
In Commercial Distribution

  • 00840155401358 ()
  • 00840155401341 ()
Not Applicable

  • Basic pillowcase, reusable
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