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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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
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
Rail Tray - Dual Track Rail Caddy
ORTHOPEDIATRICS CORP.
01-2200-0105
In Commercial Distribution

  • 00841132178799 ()
01-2200-0105

  • External orthopaedic fixation frame calculation software
Rail Tray - Wire Caddy
ORTHOPEDIATRICS CORP.
01-2200-0104
In Commercial Distribution

  • 00841132178775 ()
01-2200-0104

  • External orthopaedic fixation frame calculation software
Rail Tray - Half Pin Caddy
ORTHOPEDIATRICS CORP.
01-2200-0103
In Commercial Distribution

  • 00841132178720 ()
01-2200-0103

  • External orthopaedic fixation frame calculation software
Rail Tray - Lid
ORTHOPEDIATRICS CORP.
01-2200-0102
In Commercial Distribution

  • 00841132178706 ()
01-2200-0102

  • External orthopaedic fixation frame calculation software
Rail Tray - Base
ORTHOPEDIATRICS CORP.
01-2200-0101
In Commercial Distribution

  • 00841132178683 ()
01-2200-0101

  • External orthopaedic fixation frame calculation software
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
Demo Flight case
PLASMABIOTICS
FCD-Typhoon
In Commercial Distribution

  • 03701354404908 ()

  • Length: 71 Centimeter
  • Width: 42 Centimeter
  • Height: 35 Centimeter


  • Endoscope clean-storage system
Velox Retractor Case 6 x 9 x 1-1/2"
KOROS U.S.A., INC.
7330-94
In Commercial Distribution

  • 00840199515707 ()
  • 10840199515704 ()

  • 9x12mm
7330-94

  • Instrument tray, reusable
Discectomy Instrument Case
KOROS U.S.A., INC.
7332-80
In Commercial Distribution

  • 00840199516124 ()
  • 10840199516121 ()

  • 9x12mm
7332-80

  • Instrument tray, reusable
Vista Sterilization Case
KOROS U.S.A., INC.
7319-22
In Commercial Distribution

  • 00840199513161 ()
  • 10840199513168 ()

  • 9x12mm
7319-22

  • Instrument tray, reusable
Pro-Retractor Instrument Case
KOROS U.S.A., INC.
9900-70
In Commercial Distribution

  • 00840199542321 ()
  • 10840199542328 ()

  • 9x12mm
9900-70

  • Instrument tray, reusable
No Description
Megagen Implant Co. Ltd
KANPK2000
In Commercial Distribution

  • 08806388242757 ()
KANPK2000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
MICAkit
Megagen Implant Co. Ltd
SGIS3000
In Commercial Distribution

  • 08806388235636 ()
SGIS3000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
MICA Noble
Megagen Implant Co. Ltd
SGIS2000
In Commercial Distribution

  • 08806388235629 ()
SGIS2000

  • Dental implant/prosthesis surgical procedure kit
EZ Plus
Megagen Implant Co. Ltd
SGEZ2000
In Commercial Distribution

  • 08806388235599 ()
SGEZ2000v

  • Dental implant/prosthesis surgical procedure kit
ExFeel Internal
Megagen Implant Co. Ltd
SGEI2000
In Commercial Distribution

  • 08806388235575 ()
SGEI2000

  • Dental implant/prosthesis surgical procedure kit
ExFeel External
Megagen Implant Co. Ltd
SGEE2000
In Commercial Distribution

  • 08806388235551 ()
SGEE2000

  • Dental implant/prosthesis surgical procedure kit
Rescue
Megagen Implant Co. Ltd
SG1SD1000
In Commercial Distribution

  • 08806388235544 ()
SG1SD1000

  • Dental implant/prosthesis surgical procedure 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
Orthopedic Tray
Epix Orthopaedics Inc.
5000-00001
In Commercial Distribution

  • B2215000000010 ()
5000-00001

  • Instrument tray, reusable
No Description
Sonova AG
n/a
In Commercial Distribution

  • 07613389671063 ()
075-5887

  • Noninvasive device battery charger
No Description
Advanced Bionics AG
CI-7432
Not in Commercial Distribution

  • 07630016863875 ()


  • Cochlear implant system waterproof kit
Pillow Case, Disposable 42gsm
MEDSOURCE INTERNATIONAL LLC
MS-003PL
In Commercial Distribution

  • 00816703024256 ()
  • 00816703024249 ()
Not Applicable

  • Basic pillowcase, 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
No Description
Biomet Orthopedics, LLC
8299-18-001
In Commercial Distribution

  • 00887868568275 ()

  • Large
829918001

  • 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
Pulse Carry Case
NORMATEC INDUSTRIES LP
Pulse Carry Case
In Commercial Distribution

  • 00817369021887 ()
56005

  • Intermittent venous compression system
  • Sequential venous compression system
Common
Megagen Implant Co. Ltd
KTSTRI2000
In Commercial Distribution

  • 08806388224883 ()
KTSTRI2000

  • Dental implant/prosthesis surgical procedure kit
Common
Megagen Implant Co. Ltd
KTSMIN2000
In Commercial Distribution

  • 08806388224876 ()
KTSMIN2000

  • Dental implant/prosthesis surgical procedure kit
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
Intermezzo
Megagen Implant Co. Ltd
KINT2000
In Commercial Distribution

  • 08806388224739 ()
KINT2000

  • Dental implant/prosthesis surgical procedure kit
Common
Megagen Implant Co. Ltd
KARIN2001
In Commercial Distribution

  • 08806388224647 ()
KARIN2001

  • Dental implant/prosthesis surgical procedure kit
AnyOne Internal
Megagen Implant Co. Ltd
KAOIN2003
In Commercial Distribution

  • 08806388224593 ()
KAOIN2003

  • Dental implant/prosthesis surgical procedure kit
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