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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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Curaplex - 00818834020718

CANNULA,ADL,25'*,FLARED,25/CA
TRI-ANIM HEALTH SERVICES, INC.
301-104
In Commercial Distribution

  • 00818834021791 ()
  • 00818834020718 ()
301-104

  • Nasal oxygen cannula, basic

NORDENT MANUFACTURING INC - 00840018606265

ENCO EXPLORER 16 .125 TIPS (CA
NORDENT MANUFACTURING INC
EX16-GB
In Commercial Distribution

  • 00840018606265 ()


  • Dental surgical probe, reusable

MAXSO - 00837699000734

MH01,Head, Push Button, CA Burs
Beyes Dental Canada Inc
SL3060
In Commercial Distribution

  • 00837699000734 ()


  • Dental power tool handpiece motorless component

MAXSO - 00837699000642

CH04,Head, Latch Type, CA Burs
Beyes Dental Canada Inc
SL2010
In Commercial Distribution

  • 00837699000642 ()


  • Dental power tool handpiece motorless component

MAXSO - 00837699000635

CH02,Head, Push Botton, CA Burs
Beyes Dental Canada Inc
SL2008
In Commercial Distribution

  • 00837699000635 ()


  • Dental power tool handpiece motorless component

Darby Dental Supply, LLC - 00889813044094

HANDPIECE S/T-2 4HMTR,NCNE&CA
DARBY DENTAL SUPPLY, LLC
9523655
In Commercial Distribution

  • 00889813044094 ()
9523655

  • Dental surgical power tool motorized handpiece/set, pneumatic

800 P37,IG,2L,STD,CA - 00840828191005

800 P37,IG,2L,STD,CA
CURBELL MEDICAL PRODUCTS, INC.
BIC-19F0-E00-8
In Commercial Distribution

  • 00840828191005 ()
28955

  • Electrical mains power extension cable

VITROS - 10758750034918

VITROS Immunodiagnostic Products CA 19-9 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6177752
In Commercial Distribution

  • 20758750034915 ()
  • 10758750034918 ()
6177752

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750000555

VITROS Immunodiagnostic Products CA 19-9 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800035
In Commercial Distribution

  • 10758750000555 ()
  • 20758750000552 ()
6800035

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750000531

VITROS Immunodiagnostic Products CA 15-3 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800033
In Commercial Distribution

  • 10758750000531 ()
  • 20758750000538 ()
6800033

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

AESCULAP - 04038653423378

CHAIN W/CLIP LOCK CA.450MM
Aesculap AG
DX120R
In Commercial Distribution

  • 04038653423378 ()
DX120R

  • Dental spatula, reusable

BioMIM Mini Twin Brackets - 00840273922438

MB .018 HKS 3, 4, CA
World Class Technology Corporation
901.1031
In Commercial Distribution

  • 00840273922438 ()
901.1031

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273920564

MB .022 HKS 3, 4, CA
World Class Technology Corporation
901.2031
In Commercial Distribution

  • 00840273920564 ()
901.2031

  • Orthodontic bracket, metal

H4 - 00840273917083

H4 L 5X5 HKS 3,4,5 CA
World Class Technology Corporation
900.2061
In Commercial Distribution

  • 00840273917083 ()
900.2061

  • Orthodontic bracket, metal

H4 - 00840273917076

H4 U 5X5 HKS 3,4,5 CA
World Class Technology Corporation
900.2060
In Commercial Distribution

  • 00840273917076 ()
900.2060

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273915829

Roth .018 HKS 3, 4, CA
World Class Technology Corporation
905.1031
In Commercial Distribution

  • 00840273915829 ()
905.1031

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273915812

Roth .018 HKS 3 CA LRGTRAY
World Class Technology Corporation
905.1030-LRGTRAY
In Commercial Distribution

  • 00840273915812 ()
905.1030-LRGTRAY

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273916680

Roth .022 HKS 3 CA LRGTRAY
World Class Technology Corporation
905.2030-LRGTRAY
In Commercial Distribution

  • 00840273916680 ()
905.2030-LRGTRAY

  • Orthodontic bracket, metal

AXIOM® - 03663394169936

IMPL. CA WITH LIGHT+DEPTH STOP
ETABLISSEMENTS ANTHOGYR
10401XL
In Commercial Distribution

  • 03663394169936 ()


  • Dental power tool handpiece motorless component

ORTHOMED - B8036905450

BONE FILE # 12 CA BELL SHAPED
ORTHO-MED, INC.
OM 69-0545
In Commercial Distribution

  • B8036905450 ()


  • Bone file/rasp, manual, reusable

Alinity - 00380740146597

Alinity i CA 15-3 Assay File
Abbott GmbH
08P511A
In Commercial Distribution

  • 00380740146597 ()
08P511A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740145385

ARCHITECT CA 125 II Reagent Kit
Abbott GmbH
02K4539
In Commercial Distribution

  • 00380740145385 ()
02K4539

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740145378

ARCHITECT CA 125 II Reagent Kit
Abbott GmbH
02K4529
In Commercial Distribution

  • 00380740145378 ()
02K4529

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740145361

ARCHITECT CA 125 II Reagent Kit
Abbott GmbH
02K4524
In Commercial Distribution

  • 00380740145361 ()
02K4524

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Alinity - 00380740135508

Alinity i CA 125 II Controls
Abbott GmbH
08P4910
In Commercial Distribution

  • 00380740135508 ()
08P4910

  • Cancer antigen 125 (CA125) IVD, control

Alinity - 00380740131036

Alinity i CA 125 II Calibrators
Abbott GmbH
08P4901
In Commercial Distribution

  • 00380740131036 ()
08P4901

  • Cancer antigen 125 (CA125) IVD, calibrator

Diacap® - 04046963178116

DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter

B.BRAUN - 04046964231834

HELP HEPARIN ADSORBER 400 US/CA
B.Braun Avitum AG
7211089
Not in Commercial Distribution

  • 04046964231834 ()
  • 04046964231841 ()
7211089

  • Apheresis kit

IHC - 00810170550676

TAG-72/CA 72-4, Clone B72.3, 10ml
Slmp, LLC
(BTO) TAG-72/CA 72-4 (B72.3) Antibody (10ml)
In Commercial Distribution

  • 00810170550676 ()
MM137-10

  • Tumour-associated glycoprotein-72 (TAG72) IVD, antibody

IHC - 00810170550539

CA 15-3, Clone DBMM1, 6ml (Manual)
Slmp, LLC
(BTO) Manual CA 15-3 (DBMM1) Antibody (6ml)
In Commercial Distribution

  • 00810170550539 ()
MM12-6

  • Cancer antigen 15-3 (CA15-3) IVD, antibody

Medline Industries, Inc. - 10198459155833

RHK,CA,TORONTO EAST AVANTA DT
MEDLINE INDUSTRIES, INC.
VASC1623
In Commercial Distribution

  • 40198459155834 ()
  • 10198459155833 ()
VASC1623

  • General surgical procedure kit, non-medicated, single-use

NA - 00763000845018

CUSTOM PACK BB11S99R11 CHICO CA 1
MEDTRONIC, INC.
BB11S99R11
In Commercial Distribution

  • 00763000845018 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000848446

CUSTOM PACK BB11S99R12 CHICO CA 1
MEDTRONIC, INC.
BB11S99R12
In Commercial Distribution

  • 00763000848446 ()


  • Cardiopulmonary bypass system blood tubing set

DeRoyal - 00749756627245

SYRINGE 10CC GREEN CA LAN 50C
DEROYAL INDUSTRIES, INC.
77-400598
In Commercial Distribution

  • 50749756627240 ()
  • 00749756627245 ()


  • Angiographic syringe

KMEDIC - 24026704291599

BONE FILE # 12 CA BELL SHAPED
TELEFLEX INCORPORATED
IPN015677
In Commercial Distribution

  • 24026704291599 ()
  • 04026704291595 ()

  • Double ended Cross serrations
  • Length: 17.8 Centimeter
KM69545

  • Bone file/rasp, manual, reusable

NA - 00763000927394

CUSTOM PACK BB11S99R15 CHICO CA 1
MEDTRONIC, INC.
BB11S99R15
In Commercial Distribution

  • 00763000927394 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000723989

CUSTOM PACK BB11S99R10 CHICO CA 1
MEDTRONIC, INC.
BB11S99R10
In Commercial Distribution

  • 00763000723989 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000630225

CUSTOM PACK BB11S99R2 CHICO CA 1
MEDTRONIC, INC.
BB11S99R2
In Commercial Distribution

  • 00763000630225 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 30845854081680

2/CA SMOKESTAR 3 PORT FILTER
Conmed Corporation
MH100017
In Commercial Distribution

  • 10845854081686 ()
  • 30845854081680 ()
MH100017

  • Surgical plume evacuation system filter

DETECTABUSE - 00810042683402

Stability Control, Menu CA +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008470
In Commercial Distribution

  • 00810042683402 ()
18008470

  • Multiple drugs of abuse IVD, control

DETECTABUSE - 00810042683389

Stability Control, Menu CA -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008469
In Commercial Distribution

  • 00810042683389 ()
18008469

  • Multiple drugs of abuse IVD, control

DETECTABUSE - 00810042683273

Stability Control, Menu CA +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008421
In Commercial Distribution

  • 00810042683273 ()
18008421

  • Multiple drugs of abuse IVD, control

DETECTABUSE - 00810042683266

Stability Control, Menu CA -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008420
In Commercial Distribution

  • 00810042683266 ()


  • Multiple drugs of abuse IVD, control

Astra Tech Implant System® - 07392532002076

Hex CA Driver Long, 35 mm
Dentsply Implants Manufacturing GmbH
22549
In Commercial Distribution

  • 07392532002076 ()
22549

  • Surgical screwdriver, reusable

Astra Tech Implant System® - 07392532002069

Hex CA Driver Short, 24 mm
Dentsply Implants Manufacturing GmbH
22548
In Commercial Distribution

  • 07392532002069 ()
22548

  • Surgical screwdriver, reusable

Curaplex - 00810071637285

HUMIDIFIER,DRY,HIGH FLOW,10/CA
BOUND TREE MEDICAL, LLC
301-P3050
In Commercial Distribution

  • 00810071638008 ()
  • 00810071637285 ()
301-P3050EA

  • Non-heated respiratory humidifier

Curaplex - 00810071631214

MASK,OX,ADL,7',50/CA
BOUND TREE MEDICAL, LLC
301-180EA
In Commercial Distribution

  • 00810071630811 ()
  • 00810071631214 ()
301-180EA

  • Rebreathing oxygen face mask

Curaplex - 00810071631047

CANNULA,ADL,SOFT,25'*,25/CA
BOUND TREE MEDICAL, LLC
301-115
In Commercial Distribution

  • 00810071630644 ()
  • 00810071631047 ()
301-115

  • Tracheostomy tube cannula, single-use

Curaplex - 00810071631030

CANNULA,ADL,SOFT,14'*,50/CA
BOUND TREE MEDICAL, LLC
301-114
In Commercial Distribution

  • 00810071630637 ()
  • 00810071631030 ()
301-114

  • Tracheostomy tube cannula, single-use

Curaplex - 00810071630989

CANNULA,ADL,25FT,FLARED,25/CA
BOUND TREE MEDICAL, LLC
301-104
In Commercial Distribution

  • 00810071630583 ()
  • 00810071630989 ()
301-104

  • Tracheostomy tube cannula, single-use
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