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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Venus Cervical Plate, One Level, 22mm
SPINAL ELEMENTS
VCP122
Not in Commercial Distribution

  • 00840916118372 ()


  • Cervical total disc replacement prosthesis, non-sterile
Working insert, with ramp, one way
OLYMPUS Winter & Ibe GmbH
A20975A
In Commercial Distribution

  • 04042761020381 ()
A20975A

  • Endoscope assembly adaptor
CHI STD C SECTION OPTION ONE
Cardinal Health 200, LLC
CHIP99CS3A
In Commercial Distribution

  • 50887488042136 ()
  • 10887488042138 ()
CHIP99CS3A

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
Unger Wide Hohmann with One Tip
Avalign Technologies, Inc.
1-3001
In Commercial Distribution

  • 00190776166380 ()


  • Hand-held surgical retractor, reusable
Y-Extension Set With One Check Valve
Codan US Corporation
BC 202
In Commercial Distribution

  • 813153021002 ()
  • 10813153021009 ()


  • Intravenous administration tubing extension set
I.V. Set with one Injection Site
Codan US Corporation
B 411
In Commercial Distribution

  • 00813153020579 ()
  • 10813153020576 ()


  • Basic intravenous administration set, noninvasive
Luerlock-Extension Set with One Injection Set
Codan US Corporation
BC 591R
In Commercial Distribution

  • 00813153022375 ()
  • 10813153022372 ()


  • Intravenous administration tubing extension set
DRAPE,ACCUFIT LORAD,ONE PIECE STAGE
MEDLINE INDUSTRIES, INC.
LS702
In Commercial Distribution

  • 40884389028354 ()
  • 10884389028353 ()
LS702

  • Patient surgical drape, single-use, non-sterile
PLI,BOX CHISEL,ONE SIDED,14
Choice Spine, LP
P070-6039
In Commercial Distribution

  • 00840996137461 ()


  • Polymeric spinal interbody fusion cage
PLI,BOX CHISEL,ONE SIDED,12
Choice Spine, LP
P070-6038
In Commercial Distribution

  • 00840996137454 ()


  • Polymeric spinal interbody fusion cage
PLI,BOX CHISEL,ONE SIDED,10
Choice Spine, LP
P070-6037
In Commercial Distribution

  • 00840996137447 ()


  • Polymeric spinal interbody fusion cage
PLI,BOX CHISEL,ONE SIDED,8
Choice Spine, LP
P070-6036
In Commercial Distribution

  • 00840996137430 ()


  • Polymeric spinal interbody fusion cage
mAMP One Step Methamphetamine Test Device
ALERE SAN DIEGO, INC.
DMA-102
In Commercial Distribution

  • 10815845020451 ()
  • 00815845020454 ()
4011750099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP One Step Buprenorphine Test Device
ALERE SAN DIEGO, INC.
DBU-102
In Commercial Distribution

  • 10815845020390 ()
  • 00815845020393 ()
4081740099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COT One Step Cotinine Test Device
ALERE SAN DIEGO, INC.
DCT-102
In Commercial Distribution

  • 10815845020383 ()
  • 00815845020386 ()
4028230099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MTD One Step Methadone Test Device
ALERE SAN DIEGO, INC.
DMT-102
In Commercial Distribution

  • 10815845020246 ()
  • 00815845020249 ()
4011820099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MOP One Step Opiate Test Device
ALERE SAN DIEGO, INC.
DMO-102
In Commercial Distribution

  • 10815845020222 ()
  • 00815845020225 ()
4011790099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC One Step Cocaine Test Device
ALERE SAN DIEGO, INC.
DCO-102
In Commercial Distribution

  • 10815845020192 ()
  • 00815845020195 ()
4011730099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BZO One Step Benzodiazepines Test Device
ALERE SAN DIEGO, INC.
DBZ-102
In Commercial Distribution

  • 10815845020178 ()
  • 00815845020171 ()
4011710099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Bozeman Uterine Forceps, one large ring
Avalign Technologies, Inc.
VM57-3773
In Commercial Distribution

  • 00190776006044 ()

  • Length: 10.25 Inch


  • Uterine tenaculum
Basic Chest Drainage Unit One Chamber
Cardinal Health, Inc.
8884713100
In Commercial Distribution

  • 10884521214101 ()

  • Total Volume: 2000 Milliliter
8884713100

  • Autotransfusion system blood collection container
APEX ARTHROSCOPY TUBING SET, ONE CONNECTION
Conmed Corporation
C7120
In Commercial Distribution

  • 20845854012175 ()
  • 10845854012178 ()
  • 00845854012171 ()
C7120

  • Surgical irrigation tubing set, single-use
SCREW DRIVER 2.3mm HEX ONE BODY
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039825528 ()
CD.TP.IN.0001

  • Spinal fixation plate, non-bioabsorbable
CANDY CANE STIRRUP PAD - ONE PIECE
AADCO MEDICAL, INC.
GL-2330
In Commercial Distribution

  • 00840348529067 ()
GL-2330

  • Radiological general body-part positioner
INTRODUCER T15K ONE STEP OID BEVEL
MEDTRONIC SOFAMOR DANEK, INC.
T15K
In Commercial Distribution

  • 00643169097247 ()


  • Bone access channel kit
ADJUSTER 3990057 CAPSTONE IR ADJ ONE
MEDTRONIC SOFAMOR DANEK, INC.
3990057
In Commercial Distribution

  • 00643169091498 ()


  • Orthopaedic implant impactor, reusable
Venus Bulk Flow ONE Value-Kit PLT
Kulzer GmbH
66095388
In Commercial Distribution

  • J014660953880 ()
66095388

  • Dental composite resin
Venus Bulk Flow ONE Value-Kit Syringe
Kulzer GmbH
66095335
In Commercial Distribution

  • J014660953350 ()
66095335

  • Dental composite resin
Venus Bulk Flow ONE PLT Refill
Kulzer GmbH
66094724
In Commercial Distribution

  • J014660947240 ()
66094724

  • Dental composite resin
Venus Bulk Flow ONE Syringe Refill
Kulzer GmbH
66094723
In Commercial Distribution

  • J014660947230 ()
66094723

  • Dental composite resin
Venus Diamond PLT Sample Kit ONE
Kulzer GmbH
66081849
In Commercial Distribution

  • J014660818490 ()
66081849

  • Dental composite resin
Venus Diamond Syringe Sample Kit ONE
Kulzer GmbH
66081848
In Commercial Distribution

  • J014660818480 ()
66081848

  • Dental composite resin
Venus Pearl PLT Sample Kit ONE
Kulzer GmbH
66081847
Not in Commercial Distribution

  • J014660818470 ()
66081847

  • Dental composite resin
Venus Pearl Syringe Sample Kit ONE
Kulzer GmbH
66081846
Not in Commercial Distribution

  • J014660818460 ()
66081846

  • Dental composite resin
Venus Diamond PLT Refill 20x0.25G ONE
Kulzer GmbH
66081839
In Commercial Distribution

  • J014660818391 ()
66081839

  • Dental composite resin
Venus Diamond Syring Refill 1X4G ONE
Kulzer GmbH
66081838
In Commercial Distribution

  • J014660818381 ()
66081838

  • Dental composite resin
Venus Pearl PLT Refill 20x0.2G ONE
Kulzer GmbH
66081837
In Commercial Distribution

  • J014660818371 ()
66081837

  • Dental composite resin
Venus Pearl PLT Refill 20x0,2G ONE
Kulzer GmbH
66081837
In Commercial Distribution

  • J014660818370 ()
66081837

  • Dental composite resin
Venus Pearl Syring Refill 1x3G ONE
Kulzer GmbH
66081836
In Commercial Distribution

  • J014660818361 ()
66081836

  • Dental composite resin
Venus Pearl Syringe Refill 1x3G ONE
Kulzer GmbH
66081836
In Commercial Distribution

  • J014660818360 ()
66081836

  • Dental composite resin
TOTAL HIP ONE AND TWO PACK
MEDLINE INDUSTRIES, INC.
DYNJ67508
In Commercial Distribution

  • 10193489410495 ()
DYNJ67508

  • General surgical procedure kit, non-medicated, single-use
MASK ADULT NON REBREATHER ONE VALVE
Canadian Hospital Specialties Limited
R-2350
In Commercial Distribution

  • 50628725099670 ()
  • 00628725099675 ()
R-2350

  • Rebreathing oxygen face mask
MASK ADULT NON REBREATHER ONE VALVE
Canadian Hospital Specialties Limited
R-2250S
In Commercial Distribution

  • 50628725099526 ()
  • 00628725099521 ()
R-2250S

  • Rebreathing oxygen face mask
PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
CF1009NTPLC
In Commercial Distribution

  • 00848530089085 ()


  • CPAP/BPAP unit ambient air filter, single-use
ION ONE TOUCH ES DX INST
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
ONE TOUCH ES DX
In Commercial Distribution

  • 10190302000864 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
White, LWS, with one storage cabinet
SAKURA FINETEK U.S.A., INC.
4171-02
In Commercial Distribution

  • 00615233078186 ()
4171-02

  • Microscope slide cabinet
  • Histology tissue cassette IVD, laboratory processing, single-use
Exchange Select One Step Ovulation Predictor
SPD SWISS PRECISION DIAGNOSTICS GMBH
One Step Ovulation Predictor
Not in Commercial Distribution

  • 00614299396432 ()
  • 00633472000140 ()
  • 10614299396439 ()


  • Natural conception assistance kit
Trephine Burs Surgical Kit One Piece
ACE SURGICAL SUPPLY CO., INC.
0494512
In Commercial Distribution

  • 00614950028368 ()
0494512

  • General surgical procedure kit, non-medicated, reusable
Separating strips, coated on one side
DENTAURUM GmbH & Co.KG
018-002-00
Not in Commercial Distribution

  • J011018002000 ()
  • J011018002001 ()


  • Dental abrasive strip, single-use
ONE (1) PACKAGE - CONTAINING 10.0 CC
Xtant Medical Holdings, Inc.
SC-5210-DBM
In Commercial Distribution

  • 00849777013499 ()


  • Bone matrix implant, human-derived
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