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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CASE 7030522 INSTRUMENT TRAY 2
MEDTRONIC SOFAMOR DANEK, INC.
7030522
In Commercial Distribution

  • 00885074163857 ()


  • Instrument tray, reusable
CASE 7030521 INSTRUMENT TRAY 1
MEDTRONIC SOFAMOR DANEK, INC.
7030521
In Commercial Distribution

  • 00885074163840 ()


  • Instrument tray, reusable
CASE 7030235 SET SCREW CADDY
MEDTRONIC SOFAMOR DANEK, INC.
7030235
In Commercial Distribution

  • 00885074163833 ()


  • Instrument tray, reusable
CASE 9790918R SELF TAPPING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
9790918R
In Commercial Distribution

  • 00885074358970 ()


  • Instrument tray, reusable
NAVIO SMALL PARTS STERILIZATION CASE
Smith & Nephew, Inc.
ROB00021
In Commercial Distribution

  • 00885556693469 ()
ROB00021

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Case, Contact, Lumbar Plate, Empty
Xtant Medical Holdings, Inc.
25-CASE
In Commercial Distribution

  • 00840311232802 ()


  • Device sterilization/disinfection container, reusable
No Description
Biomet Orthopedics, LLC
593100
In Commercial Distribution

  • 00880304483866 ()
593100

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595614
In Commercial Distribution

  • 00880304479753 ()
595614

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
110010238
In Commercial Distribution

  • 00880304716278 ()
110010238

  • Device sterilization/disinfection container, reusable
No Description
Biomet Orthopedics, LLC
597004
In Commercial Distribution

  • 00880304562813 ()
597004

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
593691
In Commercial Distribution

  • 00880304562462 ()
593691

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
995152
In Commercial Distribution

  • 00880304417281 ()
995152

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595151
In Commercial Distribution

  • 00880304397149 ()
595151

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595150
In Commercial Distribution

  • 00880304397132 ()
595150

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595149
In Commercial Distribution

  • 00880304397125 ()
595149

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595148
In Commercial Distribution

  • 00880304397118 ()
595148

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595147
In Commercial Distribution

  • 00880304397101 ()
595147

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595041
In Commercial Distribution

  • 00880304396333 ()
595041

  • Instrument tray, reusable
1pc Patient Gown, 1pc Round Cup, 1pc, Slipper, 1Pillow Cover 50x 70cm, 1pc Bed Sheet with Elastic 160x 240cm - 30 Non-Sterile Pouch Copy
HEPRO.US INC.
CT - Welcome Pack
In Commercial Distribution

  • 00854427007988 ()
  • 85442700798802 ()


  • Surgical/examination garment kit
Material 43gsm A/S SMMS Color: Green - In Bulk, 50pcs/Ctn
HEPRO.US INC.
CT Lab Suit
In Commercial Distribution

  • 00854427007087 ()
  • 85442700708701 ()


  • Surgical/examination garment kit
No Description
Lina Medical ApS
MT-CASE
In Commercial Distribution

  • 05708265004980 ()
MT-CASE

  • Middle ear decompressor, positive pressure
Case (enclosure) service parts for Echoport
OTODYNAMICS LIMITED
EP-CASE-KIT
In Commercial Distribution

  • 05060396172762 ()


  • Otoacoustic emission system, line-powered
No Description
OTODYNAMICS LIMITED
OP-CAS
In Commercial Distribution

  • 05060396170454 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
Case for storage/transport of ROSC-U, with wheels
RESUSCITATION INTERNATIONAL, LLC
A03-WB-000
In Commercial Distribution

  • 00860000876285 ()
A03-WB-000

  • Cardiac resuscitator, battery-powered
Case used for carrying and/or storage of ROSC-U
RESUSCITATION INTERNATIONAL, LLC
A03-PB-000
In Commercial Distribution

  • 00860000876278 ()
A03-PB-000

  • Cardiac resuscitator, battery-powered
No Description
Biomet Orthopedics, LLC
596011
In Commercial Distribution

  • 00880304462670 ()
596011

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595629
In Commercial Distribution

  • 00880304452275 ()
595629

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
595214
In Commercial Distribution

  • 00880304436121 ()
595214

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
905459
In Commercial Distribution

  • 00880304438637 ()
905459

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
596010
In Commercial Distribution

  • 00880304427457 ()
596010

  • Instrument tray, reusable
Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, and two model DE-001 single-use electrosurgical return electrodes
Gynesonics, Inc.
CSKIT-001
Not in Commercial Distribution

  • 10817929020005 ()
CSKIT-001

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
ClearView Instrument Sterilizing Case 13 x 10 x 2
KOROS U.S.A., INC.
7319-99T
In Commercial Distribution

  • 00840199501755 ()
  • 10840199501752 ()
7319-99T

  • Instrument tray, reusable
ClearView Instrument Sterilizing Case 13 x 10 x 2
KOROS U.S.A., INC.
7319-99
In Commercial Distribution

  • 00840199501748 ()
  • 10840199501745 ()
7319-99

  • Instrument tray, reusable
Sterilizable Instrument Case for UC First Rib Arm Holding Retractor
KOROS U.S.A., INC.
9980-90
In Commercial Distribution

  • 00840199543328 ()
  • 10840199543325 ()

  • 9x12mm
9980-90

  • Instrument tray, reusable
Husky Plus Instrument Case, Holds 10 Instruments
KOROS U.S.A., INC.
7570-30
In Commercial Distribution

  • 00840199529858 ()
  • 10840199529855 ()

  • 9x12mm
7570-30

  • Instrument tray, reusable
EZ Plus Internal
Megagen Implant Co. Ltd
KEZPK3000
In Commercial Distribution

  • 08806388224715 ()
KEZPK3000

  • Dental implant/prosthesis surgical procedure kit
XPEED AnyRidge Internal Implant System H=4/ Hex
Megagen Implant Co. Ltd
C-AHAR04H
In Commercial Distribution

  • 08806388257768 ()
C-AHAR04H

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
AnyOne Internal & ST Implant System H=4/ Hex
Megagen Implant Co. Ltd
C-AHAO04H
In Commercial Distribution

  • 08806388257744 ()
C-AHAO04H

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
XPEED AnyRidge Internal Implant System H=4/ Non-Hex
Megagen Implant Co. Ltd
C-AHAR04N
In Commercial Distribution

  • 08806388257034 ()
C-AHAR04N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Otto Bock Healthcare Products GmbH
642V16
Not in Commercial Distribution

  • 04032767767700 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
BLUEDIAMOND Implant System H=4/ Non-Octa
Megagen Implant Co. Ltd
C-AHBD04N
In Commercial Distribution

  • 08809822763313 ()
C-AHBD04N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
AnyOne Internal & ST Implant System H=7/ Hex
Megagen Implant Co. Ltd
C-AHAO07H
In Commercial Distribution

  • 08809822763252 ()
C-AHAO07H

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
BLUEDIAMOND Implant System H=5/ Octa
Megagen Implant Co. Ltd
C-AHBD05O
In Commercial Distribution

  • 08809822763191 ()
C-AHBD05O

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
BLUEDIAMOND Implant System H=4/ Octa
Megagen Implant Co. Ltd
C-AHBD04O
In Commercial Distribution

  • 08809822763139 ()
C-AHBD04O

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
AnyOne Internal & ST Implant System H=5/ Non-Hex
Megagen Implant Co. Ltd
C-AHAO05N
In Commercial Distribution

  • 08809822763047 ()
C-AHAO05N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
XPEED AnyRidge Internal Implant System H=5/ Hex
Megagen Implant Co. Ltd
C-AHAR05H
In Commercial Distribution

  • 08809822762712 ()
C-AHAR05H

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
AnyOne Internal & ST Implant System H=4/ Non-Hex
Megagen Implant Co. Ltd
C-AHAO04N
In Commercial Distribution

  • 08809822762705 ()
C-AHAO04N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
BLUEDIAMOND Implant System H=7/ Non-Octa
Megagen Implant Co. Ltd
C-AHBD07N
In Commercial Distribution

  • 08809822762613 ()
C-AHBD07N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
BLUEDIAMOND Implant System H=5/ Non-Octa
Megagen Implant Co. Ltd
C-AHBD05N
In Commercial Distribution

  • 08809822762439 ()
C-AHBD05N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
XPEED AnyRidge Internal Implant System H=7/ Hex
Megagen Implant Co. Ltd
C-AHAR07H
In Commercial Distribution

  • 08809822762255 ()
C-AHAR07H

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
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