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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HFHS TOTAL JOINT PACK I
Cardinal Health 200, LLC
SOPW1TJHF4
In Commercial Distribution

  • 50195594166739 ()
  • 10195594166731 ()
SOPW1TJHF4

  • Orthopaedic surgical procedure kit, non-medicated, single-use
TOTAL KNEE PLUS I PACK
Cardinal Health 200, LLC
SOP48TKOP2
In Commercial Distribution

  • 50195594347374 ()
  • 10195594347376 ()
SOP48TKOP2

  • Orthopaedic surgical procedure kit, non-medicated, single-use
MAJOR EXTREMITY PLUS I PACK
Cardinal Health 200, LLC
SOP53MEBW5
In Commercial Distribution

  • 50195594328984 ()
  • 10195594328986 ()
SOP53MEBW5

  • Orthopaedic surgical procedure kit, medicated
C E I EAR PACK
Cardinal Health 200, LLC
SEN69CIEA2
In Commercial Distribution

  • 50195594379757 ()
  • 10195594379759 ()
SEN69CIEA2

  • ENT surgical procedure kit, non-medicated, single-use
HFHS TOTAL JOINT PACK I
Cardinal Health 200, LLC
SOPW1TJHF8
In Commercial Distribution

  • 50195594386694 ()
  • 10195594386696 ()
SOPW1TJHF8

  • Orthopaedic surgical procedure kit, non-medicated, single-use
HFHS TOTAL JOINT PACK I
Cardinal Health 200, LLC
SOPW1TJHFK
In Commercial Distribution

  • 50195594659309 ()
  • 10195594659301 ()
SOPW1TJHFK

  • Orthopaedic surgical procedure kit, non-medicated, single-use
I R LUMBAR PUNCTURE PACK
Cardinal Health 200, LLC
SAN31LPNWD
In Commercial Distribution

  • 50195594554093 ()
  • 10195594554095 ()
SAN31LPNWD

  • Angiography kit
MAJOR EXTREMITY PLUS I PACK
Cardinal Health 200, LLC
SOP53MEBW6
In Commercial Distribution

  • 50195594587473 ()
  • 10195594587475 ()
SOP53MEBW6

  • Orthopaedic surgical procedure kit, medicated
HFHS TOTAL JOINT PACK I
Cardinal Health 200, LLC
SOPW1TJHF9
In Commercial Distribution

  • 50195594598585 ()
  • 10195594598587 ()
SOPW1TJHF9

  • Orthopaedic surgical procedure kit, non-medicated, single-use
I R LUMBAR PUNCTURE PACK
Cardinal Health 200, LLC
SAN31LPN10
In Commercial Distribution

  • 50195594635914 ()
  • 10195594635916 ()
SAN31LPN10

  • Angiography kit
I R LUMBAR PUNCTURE PACK
Cardinal Health 200, LLC
SAN31LPN11
In Commercial Distribution

  • 50195594752819 ()
  • 10195594752811 ()
SAN31LPN11

  • Angiography kit
I AND D VAGINAL PACK
Cardinal Health 200, LLC
08B7483A
In Commercial Distribution

  • 50195594774651 ()
  • 10195594774653 ()
08B7483A

  • Obstetrical/gynaecological surgical procedure kit, medicated
I R LUMBAR PUNCTURE PACK
Cardinal Health 200, LLC
SAN31LPNW9
In Commercial Distribution

  • 50195594542731 ()
  • 10195594542733 ()
SAN31LPNW9

  • Angiography kit
C E I EAR PACK
Cardinal Health 200, LLC
SEN69CIEAC
In Commercial Distribution

  • 50195594536860 ()
  • 10195594536862 ()
SEN69CIEAC

  • ENT surgical procedure kit, non-medicated, single-use
!DO MATERNITY BELT WHITE I
MEDI MANUFACTURING, INC.
DP2AU71
In Commercial Distribution

  • 00636257204856 ()


  • Lumbar spine orthosis
Herpes Simplex Virus I, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB26900 ()
BSB 2690

  • Herpes simplex virus 1 (HSV1) antigen IVD, control
Herpes Simplex Virus I, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB24320 ()
BSB 2432

  • Herpes simplex virus 1 (HSV1) antigen IVD, control
Slim I/M Sleeve Adapter
Ortho Development Corporation
C-1756
In Commercial Distribution

  • 00822409114115 ()


  • Orthopaedic implant-instrument extension adaptor, reusable
Offset I/M Alignment Guide
Ortho Development Corporation
C-1731
In Commercial Distribution

  • 00822409110438 ()
C-1731

  • Osteotomy guide, reusable
Notched I/M Alignment Guide
Ortho Development Corporation
C-1715
In Commercial Distribution

  • 00822409107186 ()


  • Osteotomy guide, reusable
I/M Cut Guide Scaffolding
Ortho Development Corporation
662-0122
In Commercial Distribution

  • 00822409063642 ()
662-0122

  • Osteotomy guide, reusable
Modular I/M Rod 8mm
Ortho Development Corporation
662-0121-01
In Commercial Distribution

  • 00822409063635 ()

  • Outer Diameter: 8 Millimeter


  • Osteotomy guide, reusable
Modular I/M Rod 8mm
Ortho Development Corporation
662-0121
In Commercial Distribution

  • 00822409063628 ()

  • Outer Diameter: 8 Millimeter


  • Osteotomy guide, reusable
I/M Adapter Cap 22mm
Ortho Development Corporation
665-4022
In Commercial Distribution

  • 00822409068883 ()

  • Outer Diameter: 22 Millimeter


  • Orthopaedic implant-instrument extension adaptor, reusable
I/M Adapter Cap 20mm
Ortho Development Corporation
665-4020
In Commercial Distribution

  • 00822409068876 ()

  • Outer Diameter: 20 Millimeter


  • Orthopaedic implant-instrument extension adaptor, reusable
I/M Adapter Cap 18mm
Ortho Development Corporation
665-4018
In Commercial Distribution

  • 00822409068869 ()

  • Outer Diameter: 18 Millimeter


  • Orthopaedic implant-instrument extension adaptor, reusable
I/M Adapter Cap 16mm
Ortho Development Corporation
665-4016
In Commercial Distribution

  • 00822409068852 ()

  • Outer Diameter: 16 Millimeter


  • Orthopaedic implant-instrument extension adaptor, reusable
Stem ExtTrial I/M Extender75mm
Ortho Development Corporation
665-0015
In Commercial Distribution

  • 00822409066339 ()

  • Length: 75 Millimeter


  • Knee tibia prosthesis trial, reusable
Notched I/M Alignment Guide
Ortho Development Corporation
261-0017
In Commercial Distribution

  • 00822409046966 ()
261-0017

  • Osteotomy guide, reusable
8mm I/M Step Drill
Ortho Development Corporation
261-0009
In Commercial Distribution

  • 00822409046904 ()

  • Outer Diameter: 8 Millimeter


  • Fluted surgical drill bit, reusable
I/M Tib Alignment Rod
Ortho Development Corporation
262-0125
In Commercial Distribution

  • 00822409050383 ()
262-0125

  • Osteotomy guide, reusable
Ulnar Saw Guide Gen I
WRIGHT MEDICAL TECHNOLOGY, INC.
40100101
In Commercial Distribution

  • 00889797008631 ()
40100101

  • Osteotomy guide, reusable
MAJOR EXTREMITY PLUS I PACK
Cardinal Health 200, LLC
SOP53MEBWE
In Commercial Distribution

  • 50198956068047 ()
  • 10198956068049 ()
SOP53MEBWE

  • Orthopaedic surgical procedure kit, medicated
No Description
MEDIVANCE INSTRUMENTS LIMITED
MK5
In Commercial Distribution

  • 05060209580012 ()
I/MAC8502F /I/MAC8503F /I/MAC8508F

  • Dental abrasive air jet system
Serum Diluent
IMMCO DIAGNOSTICS, INC.
2308
In Commercial Distribution

  • 00845714004353 ()

  • 60 ml
2308

  • Buffered sample diluent IVD, manual
Enzyme Substrate
IMMCO DIAGNOSTICS, INC.
2513
In Commercial Distribution

  • 00845714002939 ()

  • 12 ML
2513

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
Bedside Monitor
NIHON KOHDEN CORPORATION
BSM-2301A
In Commercial Distribution

  • 04931921101629 ()


  • General-purpose multi-parameter bedside monitor
For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.
Wallac Oy
B128-100
Not in Commercial Distribution

  • 06438147009756 ()
B128-100

  • Buffered sample diluent IVD
For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.
Wallac Oy
B127-100
Not in Commercial Distribution

  • 06438147009749 ()
B127-100

  • Buffered sample diluent IVD
AeroTech I Shield, part of Radioaerosol Administration System
Mirion Technologies (capintec), Inc.
177-095
In Commercial Distribution

  • 00879942070101 ()
177-095

  • Radioaerosol administration set
Home pregnancy test for early results
Immunostics Company, Inc
5050M2-3B
In Commercial Distribution

  • 00722355002859 ()
  • 80722355002855 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Home pregnancy test for early results
Immunostics Company, Inc
5050M2-1B
In Commercial Distribution

  • 00722355002842 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
No Description
PREVEST DENPRO LIMITED
Large Pack
In Commercial Distribution

  • D967300032 ()
30003-2

  • Dental composite resin kit
No Description
PREVEST DENPRO LIMITED
Regular Pack
In Commercial Distribution

  • D967300031 ()
30003-1

  • Dental composite resin kit
No Description
PREVEST DENPRO LIMITED
Economy Pack
In Commercial Distribution

  • D96730003 ()
30003

  • Dental composite resin kit
No Description
PREVEST DENPRO LIMITED
Trial Pack
In Commercial Distribution

  • D967300021 ()
30002-1

  • Dental composite resin kit
No Description
PREVEST DENPRO LIMITED
Intro Pack
In Commercial Distribution

  • D96730002 ()
30002

  • Dental composite resin kit
No Description
ARUM DENTISTRY Co., Ltd.
NB16513SS
In Commercial Distribution

  • 08809917605290 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB16511SS
In Commercial Distribution

  • 08809917605283 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB16510SS
In Commercial Distribution

  • 08809917605276 ()


  • Screw endosteal dental implant, two-piece
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