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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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VITROS Immunodiagnostic Products CA 125 II Calibrators
ORTHO CLINICAL DIAGNOSTICS
6177751
In Commercial Distribution

  • 10758750034901 ()
6177751

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6177747
In Commercial Distribution

  • 20758750034830 ()
  • 10758750034833 ()
6177747

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802241
In Commercial Distribution

  • 10758750002351 ()
  • 20758750002358 ()
6802241

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 15-3 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801758
In Commercial Distribution

  • 10758750001323 ()
  • 20758750001320 ()
6801758

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 125 II Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800034
In Commercial Distribution

  • 10758750000548 ()
  • 20758750000545 ()
6800034

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
E-Type K-Style CA 1:1 Latch Chuck
SIRONA Dental Systems GmbH
710430
In Commercial Distribution

  • E2767104300 ()


  • Dental power tool handpiece motorless component
IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002611 ()
800-7211

  • Multiple urine analyte IVD, control
H4 .022 U HKS 345 7X7 CA
World Class Technology Corporation
916.2152
In Commercial Distribution

  • 00840273920984 ()
916.2152

  • Orthodontic bracket, metal
H4 .022 L HKS 345 7X7 CA
World Class Technology Corporation
916.2151
In Commercial Distribution

  • 00840273920977 ()
916.2151

  • Orthodontic bracket, metal
Roth .018 HKS 3, 4, CA LRGTRAY
World Class Technology Corporation
905.1031-LRGTRAY
In Commercial Distribution

  • 00840273915836 ()
905.1031-LRGTRAY

  • Orthodontic bracket, metal
Roth .022 HKS 3, 4, CA LRGTRAY
World Class Technology Corporation
905.2031-LRGTRAY
In Commercial Distribution

  • 00840273916703 ()
905.2031-LRGTRAY

  • Orthodontic bracket, metal
Alinity i CA 125 II Assay File
Abbott GmbH
08P491A
In Commercial Distribution

  • 00380740146603 ()
08P491A

  • Laboratory instrument/analyser application software IVD
277-10-418 FAST CTNG MICRO BUR,RND,CA
MEDLINE INDUSTRIES, INC.
27710418RH
In Commercial Distribution

  • 10888277388420 ()
27710418RH

  • Orthopaedic bur, single-use
4500-99 SCOPE MOUNTING BLADE W/CLEAR CA
MEDLINE INDUSTRIES, INC.
450099R
In Commercial Distribution

  • 20888277370637 ()
  • 10888277370630 ()
450099R

  • Hand ligament surgical release instrument
Pack Patient F/ Univ S CA Perio
HENRY SCHEIN, INC.
5703238
In Commercial Distribution

  • H65857032381 ()
  • H65857032385 ()
5703238

  • General surgical procedure kit, non-medicated, single-use
TAG-72/CA 72-4, Clone B72.3, 6ml (Manual)
Slmp, LLC
(BTO) Manual TAG-72/CA 72-4 (B72.3) Antibody (6ml)
In Commercial Distribution

  • 00810170550683 ()
MM137-6

  • Tumour-associated glycoprotein-72 (TAG72) IVD, antibody
CA OF MI #11642 ILR IMPLANT PACK
DEROYAL INDUSTRIES, INC.
89-10714
In Commercial Distribution

  • 50749756374366 ()
  • 00749756374361 ()
89-10714

  • General surgical procedure kit, non-medicated, single-use
KIT,HIMA TOTAL PBDS TOT HIP CA
Cardinal Health 200, LLC
PO30THHR8
In Commercial Distribution

  • 50197106124503 ()
  • 10197106124505 ()
PO30THHR8

  • Orthopaedic surgical procedure kit, medicated
HIGH FLOW START KIT,7'*,10/CA
BOUND TREE MEDICAL, LLC
P3052EA
In Commercial Distribution

  • 00810071638015 ()
  • 00810071637292 ()
301-P3052EA

  • Non-heated respiratory humidifier
MASK,TRACH,ADULT,CURAPLEX,SPU,50/CA
BOUND TREE MEDICAL, LLC
301-184
In Commercial Distribution

  • 00810071630880 ()
  • 00810071631283 ()
301-184

  • Tracheostomy mask, oxygen
TEE,AEROSOL,22MX22MX15F 50/BG 100/CA
BOUND TREE MEDICAL, LLC
301-160EA
In Commercial Distribution

  • 00810071630767 ()
  • 00810071631160 ()
301-160EA

  • Non-rebreathing valve, single-use
Rabbit Monoclonal Anti-Human CA 125 (48), concentrated
Epitomics Inc.
AC-0046BULK
In Commercial Distribution

  • 00810113061405 ()


  • Cancer antigen 125 (CA125) IVD, antibody
CS7600 Imaging System for US, CA, Brazil
CARESTREAM HEALTH, INC.
CS 7600
In Commercial Distribution

  • 60889971068408 ()
1068402

  • Dental computed radiography digital imaging scanner
PVC Anesthesia Mask #2, Pediatric, 150/CA
VENTLAB, LLC
812-0007-01
Not in Commercial Distribution

  • 30889483271036 ()
812-0007-01

  • Anaesthesia face mask, single-use
PVC Anesthesia Mask #1, Infant, 200/CA
VENTLAB, LLC
812-0006-01
In Commercial Distribution

  • 30889483271012 ()
812-0006-01

  • Anaesthesia face mask, single-use
SYRINGE 0.3ML 29GA 1/2IN 200BX CA
BECTON, DICKINSON AND COMPANY
324702
Not in Commercial Distribution

  • 10382903247025 ()
  • 50382903247023 ()
  • 80382903247024 ()

  • Needle Gauge: 29 Gauge
  • Length: 12.77 Millimeter
324702

  • Insulin syringe/needle, basic
IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002680 ()
800-7702

  • Multiple urine analyte IVD, control
FOREFOOT/ MIDFOOT WIRES. DRILLS. & DRILL GUIDE CA
Smith & Nephew, Inc.
CSA-1001-10
In Commercial Distribution

  • 00885556839614 ()
CSA-1001-10

  • Instrument tray, reusable
Gs/Gw Drive Lock CA Long Wide
INTRA-LOCK INTERNATIONAL, INC.
SDLCALW
In Commercial Distribution

  • D742SDLCALW0 ()
SDLCALW

  • Dental implant system
25g x 7/8" Lasik Irrig Ca
STERIMEDIX LIMITED
M2822-02/10
In Commercial Distribution

  • 25056030400296 ()
  • 35056030400477 ()
M2822

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
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