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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Common
Megagen Implant Co. Ltd
KTSMID2000
In Commercial Distribution

  • 08806388224869 ()
KTSMID2000

  • Dental implant/prosthesis surgical procedure kit
MILA
Megagen Implant Co. Ltd
KLSCN2000
In Commercial Distribution

  • 08806388224753 ()
KLSCN2000

  • Dental implant/prosthesis surgical procedure kit
No Description
Megagen Implant Co. Ltd
KANPK2000
In Commercial Distribution

  • 08806388242757 ()
KANPK2000

  • 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
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
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9911
In Commercial Distribution

  • 00848665024043 ()


  • Instrument tray, reusable
Storage case for Flat Panel Senser
FUJIFILM CORPORATION
DR602 SE CASE E
In Commercial Distribution

  • 04547410193565 ()


  • Stationary basic diagnostic x-ray system, digital
Storage case for Flat Panel Senser
FUJIFILM CORPORATION
DR600 SE CASE E
In Commercial Distribution

  • 04547410134667 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9974-000
In Commercial Distribution

  • 00848665039283 ()


  • Surgical instrument/implant rack
Dental Implant Surgical Instrument - KIT Bone Tack Case
Ossvis Co., Ltd.
HSBTC
In Commercial Distribution

  • 08809918249844 ()


  • Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-592-409
In Commercial Distribution

  • 09348215134921 ()


  • 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
CardioTek B.V.
08ACC01
In Commercial Distribution

  • 04260441450574 ()


  • Cardiac electrophysiology analysis system
Carry Case, Universal, Activox
RESMED ASIA PTE. LTD.
123-102
Not in Commercial Distribution

  • 09353645000081 ()


  • Personal device holder, 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
KaVo Dental GmbH
1.009.5746
In Commercial Distribution

  • EKAV100957460 ()
619460C

  • Dental power tool system handpiece, pneumatic
No Description
PRO-DEX, INC.
60.000.010
In Commercial Distribution

  • 00860540000201 ()
  • 10860540000208 ()


  • Device sterilization/disinfection container, reusable
SONTEC BLACK CASE
SONTEC INSTRUMENTS, INC.
C-079.05.000
Not in Commercial Distribution

  • 00192896071629 ()

  • Width: 13 Inch
  • Length: 16.25 Inch
  • Height: 6 Inch
C-079.05.000

  • General physical examination set
Sontec Calvian Case
SONTEC INSTRUMENTS, INC.
18-3566
In Commercial Distribution

  • 00192896115699 ()

  • Length: 10 Inch
  • Width: 10 Inch
  • Depth 2.0 Inch
18-3566

  • Instrument tray, reusable
Tray System Case
MIAMI DEVICE SOLUTIONS LLC
MDS001203
In Commercial Distribution

  • 10812269023167 ()
MDS001203

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
  • Instrument transport trolley system
No Description
Megagen Implant Co. Ltd
ARPK2000
In Commercial Distribution

  • 08806388285969 ()
ARPK2000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
THINK SURGICAL, INC.
109939
In Commercial Distribution

  • M9461099390 ()
109939

  • Stereotactic system application software
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
Reusable instrument storage case that is used to contain the reusable instruments during sterilization processing in preparation for pelvic fixation procedure.
Curvafix Inc
CIC-003
In Commercial Distribution

  • 10855068008539 ()
CIC-003

  • Device sterilization/disinfection container, reusable
Reusable instrument storage case that is used to contain the reusable instruments during sterilization processing in preparation for pelvic fixation procedure.
Curvafix Inc
CIC-001
In Commercial Distribution

  • 10855068008393 ()
CIC-001

  • Device sterilization/disinfection container, reusable
Pulse Carry Case
NORMATEC INDUSTRIES LP
Pulse Carry Case
In Commercial Distribution

  • 00817369021887 ()
56005

  • Intermittent venous compression system
  • Sequential venous compression system
Case 2 Complete
Tecomet
2500-00-794
In Commercial Distribution

  • 00817766026461 ()


  • Device sterilization/disinfection container, reusable
No Description
Zimmer, Inc.
4802
In Commercial Distribution

  • 00889024068254 ()
00-4802-000-00

  • Device sterilization/disinfection container, reusable
No Description
Zimmer, Inc.
2800-90
In Commercial Distribution

  • 00889024064799 ()
00-2800-090-00

  • Device sterilization/disinfection container, reusable
No Description
Zimmer, Inc.
2800-85
In Commercial Distribution

  • 00889024064782 ()
00-2800-085-00

  • Device sterilization/disinfection container, reusable
Pillow Case, Disposable 42gsm
MEDSOURCE INTERNATIONAL LLC
MS-003PL
In Commercial Distribution

  • 00816703024256 ()
  • 00816703024249 ()
Not Applicable

  • Basic pillowcase, reusable
Orthopedic Tray
Epix Orthopaedics Inc.
5000-00001
In Commercial Distribution

  • B2215000000010 ()
5000-00001

  • Instrument tray, reusable
No Description
Advanced Bionics AG
CI-7432
Not in Commercial Distribution

  • 07630016863875 ()


  • Cochlear implant system waterproof kit
Q-Optics Loupe Case
Quality Aspirators, Inc.
Q-Optics Loupe Case
In Commercial Distribution

  • 00814005024240 ()
308-10034

  • Surgical binoculars, reusable
Prism Combo Case
Quality Aspirators, Inc.
Prism Combo Case
In Commercial Distribution

  • 00814005023496 ()
308-10042

  • Surgical binoculars, reusable
No Description
Sonova AG
n/a
In Commercial Distribution

  • 07613389671063 ()
075-5887

  • Noninvasive device battery charger
No Description
Biomet Orthopedics, LLC
8299-18-001
In Commercial Distribution

  • 00887868568275 ()

  • Large
829918001

  • Instrument tray, reusable
Twin Transport Case for the Novoste Beta-Cath System
BEST VASCULAR, INC.
TRC-0002
In Commercial Distribution

  • M097TRC00020 ()
TRC-0002

  • Manual-afterloading brachytherapy system source transfer device transport case/set
Lubricated male latex condom- Atlas Colors 12 pack case (8 bundles of 6)
GLOBAL PROTECTION CORP.
10102C
In Commercial Distribution

  • 20726893111169 ()
  • 80726893111161 ()


  • Basic male condom, Hevea-latex
No Description
Biomet Orthopedics, LLC
14175
In Commercial Distribution

  • 00887868002250 ()

  • 6.5MM
14175.

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
10760
In Commercial Distribution

  • 00887868001611 ()
10760

  • Instrument tray, reusable
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