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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Large Standalone Cage Implant & Trial Case (39 & 42mm)
PRECISION SPINE, INC.
69-SC-0400
In Commercial Distribution

  • 00840019968225 ()
69-SC-0400

  • Polymeric spinal interbody fusion cage
Standalone Cage Implant & Trial Case (30, 33, & 36mm)
PRECISION SPINE, INC.
69-SC-0100
In Commercial Distribution

  • 00840019968058 ()
69-SC-0100

  • Polymeric spinal interbody fusion cage
OR TOWEL, BLUE, COTTON, PRE-WASHED, NON-STERILE, 400/CASE
ALLCARE, INC
ORB-400
In Commercial Distribution

  • 00182921000014 ()
  • 00182921000175 ()
ORB-400

  • Surgical towel
Reform® Modular Pedicle Screw Instrument Case 1
PRECISION SPINE, INC.
39-SC-0501
In Commercial Distribution

  • 00840019929097 ()
39-SC-0501

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Reform® MIS Reduction Uniplanar Implant Case (Empty)
PRECISION SPINE, INC.
39-SC-0401
In Commercial Distribution

  • 00840019929059 ()
39-SC-0401

  • Orthopaedic surgical procedure kit, non-medicated, reusable
MD-Max™ Triple Lead MIS Instrument Case - Empty
PRECISION SPINE, INC.
43-8200
In Commercial Distribution

  • 00840019926188 ()
43-8200

  • Instrument tray, reusable
Portable case with Belt for 2301/2302 Recorders
VASOMEDICAL, INC.
Model 2301
In Commercial Distribution

  • 00817980020641 ()
A10-0043

  • Electrocardiographic lead set, reusable
Portable case with Belt for 1304/1305 Recorder
VASOMEDICAL, INC.
Model 1304
In Commercial Distribution

  • 00817980020627 ()
A10-0042

  • Electrocardiographic lead set, reusable
OR TOWEL, 17X26 BLUE, LOW LINT, 500/CASE
CENTURION MEDICAL PRODUCTS CORPORATION
SB017026500B
In Commercial Distribution

  • 00653160298673 ()
  • 10653160298670 ()
SB017026500B

  • Surgical towel
RISERVA VINYL EXAMINATION GLOVES XLARGE CASE OF 1500
Mohawk Hospital Equipment, Inc.
BASVGPF40041
In Commercial Distribution

  • G378BASVGPF40041 ()
BASVGPF4004

  • Vinyl examination/treatment glove, non-powdered
RISERVA VINYL EXAMINATION GLOVES LARGE CASE OF 1500
Mohawk Hospital Equipment, Inc.
BASVGPF40031
In Commercial Distribution

  • G378BASVGPF40031 ()
BASVGPF4003

  • Vinyl examination/treatment glove, non-powdered
RISERVA VINYL EXAMINATION GLOVES MEDIUM CASE OF 1500
Mohawk Hospital Equipment, Inc.
BASVGPF40021
In Commercial Distribution

  • G378BASVGPF40021 ()
BASVGPF4002

  • Vinyl examination/treatment glove, non-powdered
RISERVA VINYL EXAMINATION GLOVES SMALL CASE OF 1500
Mohawk Hospital Equipment, Inc.
BASVGPF40011
In Commercial Distribution

  • G378BASVGPF40011 ()
BASVGPF4001

  • Vinyl examination/treatment glove, non-powdered
RISERVA NITRILE EXAMINATION GLOVES XLARGE CASE OF 1800
Mohawk Hospital Equipment, Inc.
BASNGPF30042
In Commercial Distribution

  • G378BASNGPF30041 ()
BASNGPF3004

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
RISERVA NITRILE EXAMINATION GLOVES LARGE CASE OF 2000
Mohawk Hospital Equipment, Inc.
BASNGPF30031
In Commercial Distribution

  • G378BASNGPF30031 ()
BASNGPF3003

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
RISERVA NITRILE EXAMINATION GLOVES MEDIUM CASE OF 2000
Mohawk Hospital Equipment, Inc.
BASNGPF30021
In Commercial Distribution

  • G378BASNGPF30021 ()
BASNGPF3002

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
RISERVA NITRILE EXAMINATION GLOVES SMALL CASE OF 2000
Mohawk Hospital Equipment, Inc.
BASNGPF30011
In Commercial Distribution

  • G378BASNGPF30011 ()
BASNGPF3001

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Knit Pants, 4XL, White, 25/bg, 4bg/case
SVS LLC
3647
In Commercial Distribution

  • 00818566017703 ()
3647

  • Incontinence pants, single-use
MODULE CASE FOR CSLP VARIABLE ANGLE 4 LEVEL
Synthes GmbH
304.985
In Commercial Distribution

  • H9813049850 ()
  • 10705034768328 ()
304985

  • Instrument tray, reusable
IMPLANT TRAY 6 FOR USE WITH STANDARD CASE
SYNTHES (U.S.A.) LP
302.31
In Commercial Distribution

  • H981302310 ()
  • 10705034767697 ()
30231

  • Instrument tray, reusable
INSTRUMENT TRAY A11 FOR USE WITH STANDARD CASE
SYNTHES (U.S.A.) LP
302.30
In Commercial Distribution

  • H981302300 ()
  • 10705034767680 ()
30230

  • Instrument tray, reusable
INSTRUMENT TRAY A2 FOR USE WITH STANDARD CASE
SYNTHES (U.S.A.) LP
302.25
In Commercial Distribution

  • H981302250 ()
  • 10705034767673 ()
30225

  • Instrument tray, reusable
DEPUY SPINE CABLE SYSTEM BY SONGER INSTRUMENT CASE
DEPUY SPINE, LLC
7825099
In Commercial Distribution

  • 10705034007564 ()
7825099

  • Instrument tray, reusable
JAGUAR LUMBAR I/F CAGE SYSTEM IMPLANT CASE
DEPUY SPINE, LLC
6000980
In Commercial Distribution

  • 10705034007250 ()
6000980

  • Instrument tray, reusable
JAGUAR LUMBAR I/F CAGE SYSTEM IMPLANT CASE
DEPUY SPINE, LLC
273126100
Not in Commercial Distribution

  • 10705034186887 ()
273126100

  • Instrument tray, reusable
Irix A Sterlization Case, Anterior Lumbar Disc Prep
Xtant Medical Holdings, Inc.
X080-0007
In Commercial Distribution

  • M697X08000070 ()
  • M697X08000071 ()


  • Instrument tray, reusable
KIT, FIRST AID & TRAUMA RESPONSE - CLASS B - CASE
NORTH AMERICAN RESCUE, LLC
80-1034
In Commercial Distribution

  • 00842209112845 ()
80-1034

  • First aid kit, medicated
KIT, FIRST AID & TRAUMA RESPONSE - CLASS A - CASE
NORTH AMERICAN RESCUE, LLC
80-1033
In Commercial Distribution

  • 00842209112777 ()
80-1033

  • First aid kit, medicated
T-Box Sterilization Case Assembly, Al, SST, Nylon, SIlicone
Innovasis, Inc.
BTB-01
In Commercial Distribution

  • M711BTB010 ()


  • Instrument tray, reusable
Case, Implant Sterilization, Px, Al, SST, Nylon, Silicone
Innovasis, Inc.
BTA-94
In Commercial Distribution

  • M711BTA940 ()


  • Instrument tray, reusable
Sterilization Case, Xpress 2 Dual Lead MIS, Implants
Xtant Medical Holdings, Inc.
X073-0036
In Commercial Distribution

  • M697X07300360 ()
  • M697X07300361 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case II, Xpress 2 Dual Lead, Implants
Xtant Medical Holdings, Inc.
X073-0016
In Commercial Distribution

  • M697X07300160 ()
  • M697X07300161 ()


  • Device sterilization/disinfection container, reusable
StatSensor StatStrip Docking Station for Wireless Carrying Case
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480486290 ()
  • 00385480486293 ()
48629

  • Glucose monitoring system IVD, point-of-care
SideStream DIsposable with Angled Mouthpiece, Case of 100
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730001494 ()
1072039

  • Benchtop nebulizer, non-heated
STERILIZATION CASE IM NAIL LONG HIP NAILS TRAY
ORTHOPAEDIC IMPLANT COMPANY, THE
01-IM55
In Commercial Distribution

  • M69601IM550 ()


  • Device sterilization/disinfection container, reusable
STERILIZATION CASE IM NAIL HIP AND FEMUR TRAY
ORTHOPAEDIC IMPLANT COMPANY, THE
01-IM54
In Commercial Distribution

  • M69601IM540 ()


  • Device sterilization/disinfection container, reusable
APEX Gen II Cross Connector Case w/lid
SPINECRAFT, LLC
6000-500
In Commercial Distribution

  • 00193082155444 ()
6000-500

  • General internal orthopaedic fixation system implantation kit
BK 1/W,wall version, trial lens case
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
33280
Not in Commercial Distribution

  • 04049584001443 ()


  • Trial lens frame
BK S1/W, wall version, trial lens case
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
33197
In Commercial Distribution

  • 04049584001405 ()


  • Trial lens frame
BK S1/T, table version, trial lens case
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
33190
In Commercial Distribution

  • 04049584001290 ()


  • Trial lens frame
BK 1/T, table version, trial lens case
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
33180
Not in Commercial Distribution

  • 04049584001191 ()


  • Trial lens frame
BURGUNDY CORNER POST FOR 56MM HIGH GRAPHIC CASE
Synthes GmbH
306.86
In Commercial Distribution

  • H679306860 ()
  • 10886982185440 ()
30686

  • Surgical instrument/implant rack
SMALL FRAGMENT SET GRAPHIC CASE TI SELF-TAPPING SCREW
SYNTHES (U.S.A.) LP
304.445
Not in Commercial Distribution

  • H6793044450 ()
  • 10886982183897 ()
304445

  • Surgical instrument/implant rack
SMALL FRAGMENT SET--LC-DCP® CASE F/SLF-TPNG SCREWS
Synthes GmbH
304.355
In Commercial Distribution

  • H6793043550 ()
  • 10886982183637 ()
304355

  • Surgical instrument/implant rack
SMALL FRAGMENT INSTR/IMPLANT SET--LC-DCP® GRAPHIC CASE
SYNTHES (U.S.A.) LP
304.350
Not in Commercial Distribution

  • 07611819817319 ()
  • H6793043500 ()
  • 10886982183613 ()
304350

  • Surgical instrument/implant rack
3.0MM CANN SCREW SET GRAPHIC CASE SCREW RACK
Synthes GmbH
304.334
In Commercial Distribution

  • 07611819707191 ()
  • H6793043340 ()
  • 10886982183545 ()
304334

  • Surgical instrument/implant rack
3.0MM CANNULATED SCREW INSTR & IMPLANT SET GRAPHIC CASE
Synthes GmbH
304.330
In Commercial Distribution

  • 07611819086098 ()
  • H6793043300 ()
  • 10886982183538 ()
304330

  • Surgical instrument/implant rack
DCS® ONE-STEP UNIVERSAL IMPLANT SET GRAPHIC CASE
Synthes GmbH
304.295
In Commercial Distribution

  • H6793042950 ()
  • 10886982183408 ()
304295

  • Surgical instrument/implant rack
DHS®/DCS® BASIC SET GRAPHIC CASE
Synthes GmbH
304.257
In Commercial Distribution

  • 07611819681668 ()
  • H6793042570 ()
  • 10886982183262 ()
304257

  • Surgical instrument/implant rack
7.0MM CANNULATED SCREW INSTR & IMPLANT SET GRAPHIC CASE
Synthes GmbH
304.230
In Commercial Distribution

  • 07611819016873 ()
  • H6793042300 ()
  • 10886982183163 ()
304230

  • Surgical instrument/implant rack
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