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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UPORAL C cup CA, pu: 6 pcs
DFS - DIAMON GmbH
800946
In Commercial Distribution

  • 04057176147264 ()
  • 04057176147271 ()


  • Dental polishing brush
UPORAL C Intro Set CA 2pcs ass.
DFS - DIAMON GmbH
800909
In Commercial Distribution

  • 04057176147233 ()


  • Dental polishing brush
1.6mm Short CA Driver Stem, Dental Latch
OSTEOMED LLC
220-0390
In Commercial Distribution

  • 00845694031561 ()
220-0390

  • General internal orthopaedic fixation system implantation kit
EasyLyte Na/K/Cl/Ca/Li Analyzer
MEDICA CORPORATION
2030
In Commercial Distribution

  • 00386100002930 ()
2030

  • Ion-selective analyser IVD
EasyLyte Calcium Na/K/Ca/pH Analyzer
MEDICA CORPORATION
2016
In Commercial Distribution

  • 00386100002893 ()
2016

  • Ion-selective analyser IVD
Connecting adapter cryo probe to Erbokryo CA
Erbe Elektromedizin GmbH
20416-035
In Commercial Distribution

  • 04050147019515 ()
20416-035

  • General cryosurgical system, cryogen gas, mechanical
CH02, Head, Push Button Type, CA Burs
Beyes Dental Canada Inc
SL2008
In Commercial Distribution

  • 00628504370544 ()


  • Dental power tool system handpiece, pneumatic
OUSIA bioKOTE 20MMX40MMX3MM 10/BOX 25BOXES/CA
ACE SURGICAL SUPPLY CO., INC.
OUSKT
In Commercial Distribution

  • 10614950007704 ()
  • 00614950007707 ()

  • Length: 40 Millimeter
  • Width: 20 Millimeter
OUSKT

  • General oral wound dressing, animal-derived
4.75 COUNTERSINK DRILL CA 24TL II TI/
ACE SURGICAL SUPPLY CO., INC.
04962501
In Commercial Distribution

  • 00614950010622 ()
04962501

  • Fluted surgical drill bit, reusable
CA 19-9 Diluent (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10491972
In Commercial Distribution

  • 00630414577128 ()
  • 00630414005874 ()
10491972

  • Buffered sample diluent IVD
CENTRAL LINE INSERT KIT W/O CA
MEDLINE INDUSTRIES, INC.
CVI3755
In Commercial Distribution

  • 10193489819434 ()
  • 40193489819435 ()
CVI3755

  • General surgical procedure kit, non-medicated, single-use
Monoclonal Mouse Anti-Human CA 19-9 Clone 1116-NS-19-9
AGILENT TECHNOLOGIES, INC.
M3517
In Commercial Distribution

  • 05700571102121 ()

  • Total Volume: 1 Milliliter


  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody
Phosphate Buffered Saline with Mg++ and Ca++
CLARK LABORATORIES, INC.
B1029-40
Not in Commercial Distribution

  • 05391516747301 ()

  • 1 x 50mL
B1029-40

  • Buffered isotonic saline reagent IVD
S1 200DT Sgl CA 1600 Dual MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007329 ()
C12S72

  • Operating room light
S1 200DT 1300mm CA Rad shield OT50001FA
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007190 ()
C12S5R

  • Operating room light
S1 200DT 2250mm CA 3P DY SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006155 ()
C12S93

  • Operating room light
S1 200DT Sgl CA 1750 Rad shield
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003789 ()
C12S8R

  • Operating room light
S1 200DT Sgl CA 1150 Dual MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003543 ()
C12S42

  • Operating room light
S1 200DT Triple CA 1150,1000,850 DY 3xSL-30M
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706001327 ()
C12T432333

  • Operating room light
Personal Use Kit OC-Auto, for Mather, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 213264
In Commercial Distribution

  • 00816917021706 ()


  • Faecal occult blood IVD, reagent
KS 9.0 T Kit Monaural CA (bronze)
Sonova AG
051-0159-U156
In Commercial Distribution

  • 07613389312676 ()
051-0159-U156

  • Air-conduction hearing aid, behind-the-ear
KS 9.0 T Kit Binaural CA (bronze)
Sonova AG
051-0148-U156
In Commercial Distribution

  • 07613389313055 ()
051-0148-U156

  • Air-conduction hearing aid, receiver-in-canal
KS 9.0 T Kit Binaural CA (beige)
Sonova AG
051-0148-H056
In Commercial Distribution

  • 07613389313024 ()
051-0148-H056

  • Air-conduction hearing aid, receiver-in-canal
KS 9.0 T Kit Binaural CA (stone)
Sonova AG
051-0148-D056
In Commercial Distribution

  • 07613389312553 ()
051-0148-D056

  • Air-conduction hearing aid, receiver-in-canal
KS 9.0 Kit Monaural CA (velvet black)
Sonova AG
051-0115-P856
In Commercial Distribution

  • 07613389356014 ()
051-0115-P856

  • Air-conduction hearing aid, receiver-in-canal
KS 9.0 Kit Monaural CA (silver gray)
Sonova AG
051-0115-P656
In Commercial Distribution

  • 07613389356007 ()
051-0115-P656

  • Air-conduction hearing aid, receiver-in-canal
Univers Revers CA Head & 155 Trials Case
ARTHREX, INC.
AR-9501H-CA155C
In Commercial Distribution

  • 00888867399372 ()
AR-9501H-CA155C

  • Device sterilization/disinfection container, reusable
Instrument Case, Rev CA Head & Adptr Trl
ARTHREX, INC.
AR-9501HC-RCAC
In Commercial Distribution

  • 00888867225077 ()
AR-9501HC-RCAC

  • Device sterilization/disinfection container, reusable
KS 9.0 T Kit Monaural CA (beige)
Sonova AG
051-0159-H056
In Commercial Distribution

  • 07613389356540 ()
051-0159-H056

  • Air-conduction hearing aid, behind-the-ear
KS 9.0 T Kit Monaural CA (stone)
Sonova AG
051-0159-D056
In Commercial Distribution

  • 07613389356533 ()
051-0159-D056

  • Air-conduction hearing aid, behind-the-ear
SUCT CATH.KIT,10FR,CUP,GRADUAT 50/CA
TRI-ANIM HEALTH SERVICES, INC.
301-002-11210EA
In Commercial Distribution

  • 00812574029611 ()
  • 00812574029604 ()
301-002-11210EA

  • Airway suction catheter
PACK FACE LIFT EENT F/ CA CUSTOM
HENRY SCHEIN, INC.
5703230
In Commercial Distribution

  • 00304040167380 ()
  • 10304040167387 ()
5703230

  • General surgical procedure kit, non-medicated, single-use
PACK PATIENT F/ UNIV S CA CUSTOM
HENRY SCHEIN, INC.
5703239
In Commercial Distribution

  • 00304040166956 ()
  • 10304040166953 ()
5703239

  • General surgical procedure kit, non-medicated, single-use
CANNULA,ADL,SOFT,14'*,UNIV,50/CA
BOUND TREE MEDICAL, LLC
301-PSCU114
In Commercial Distribution

  • 00812277038453 ()
  • 00812277037197 ()
301-PSCU114

  • Tracheostomy tube cannula, single-use
MASK,VENTURI,PED,CURAPLEX,SPU 50/CA
BOUND TREE MEDICAL, LLC
301-192
In Commercial Distribution

  • 00812277036350 ()
  • 00812277036343 ()
301-192

  • Venturi oxygen face mask
EXTRA SHORT RETENTIVE CA DRIVER OUTLINK2-GLOBAL MOUNTER
SWEDEN & MARTINA SPA
E2-AVV3-MOUC-CA
In Commercial Distribution

  • D7701107403 ()
E2-AVV3-MOUC-CA

  • Dental implant/prosthesis surgical procedure kit
EASY MOUNTER PREMIUM ONE CA, SLEEVE 550
SWEDEN & MARTINA SPA
GS-EASY-AS-550-CA
In Commercial Distribution

  • D7701515563 ()
GS-EASY-AS-550-CA

  • Surgical screwdriver, reusable
EASY MOUNTER PREMIUM ONE CA, SLEEVE 415
SWEDEN & MARTINA SPA
GS-EASY-AS-415-CA
In Commercial Distribution

  • D7701515553 ()
GS-EASY-AS-415-CA

  • Surgical screwdriver, reusable
TEE,AEROSOL,22MX22MX15F 50/BG 100/CA
TRI-ANIM HEALTH SERVICES, INC.
301-160EA
In Commercial Distribution

  • 00818834021432 ()
  • 00818834020893 ()
  • 00818834021975 ()
301-160EA

  • Oxygen administration tubing
PrimePlus Bariatric Bed, 750 lb. Wgt Ca
Drive Devilbiss Healthcare
P1752
Not in Commercial Distribution

  • 00822383550626 ()


  • Bariatric bed
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
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