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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ARCHITECT i System e-Assay CD-ROM-US Version 25.0
ABBOTT LABORATORIES
04P5525
In Commercial Distribution

  • 00380740204082 ()
04P5525

  • Laboratory instrument/analyser application software IVD
Alinity i HAVAb IgG II Assay File
Abbott GmbH
06S931A
In Commercial Distribution

  • 00380740197544 ()
06S931A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM-US Version 23.0
ABBOTT LABORATORIES
04P5523
In Commercial Distribution

  • 00380740192754 ()
04P5523

  • Laboratory instrument/analyser application software IVD
Alinity i CMV IgG Reagent Kit (200T)
Abbott Ireland Diagnostics
07P4224
In Commercial Distribution

  • 00380740181093 ()
07P4224

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Alinity s HTLV I/II e-Assay File
Abbott GmbH
06P075A
In Commercial Distribution

  • 00380740162948 ()
06P075A

  • Laboratory instrument/analyser application software IVD
Alinity i DHEA-S Reagent Kit 200 Tests
Abbott GmbH
09P3720
In Commercial Distribution

  • 00380740156336 ()
09P3720

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Alinity i Anti-TPO Reagent Kit 200 Tests
Abbott Ireland Diagnostics
09P3521
In Commercial Distribution

  • 00380740153892 ()
09P3521

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay
Alinity i Homocysteine Reagent Kit 200 Tests
Abbott GmbH
09P2820
In Commercial Distribution

  • 00380740153496 ()
09P2820

  • Homocysteine IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBs Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P8856
In Commercial Distribution

  • 00380740149611 ()
07P8856

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Anti-Tg Reagent Kit 200 Tests
Abbott Ireland Diagnostics
09P3420
In Commercial Distribution

  • 00380740149550 ()
09P3420

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Alinity i B12 Reagent Kit 1200 Tests
ABBOTT IRELAND
07P6731
In Commercial Distribution

  • 00380740136703 ()
07P6731

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Alinity i B12 Reagent Kit 200 Tests
ABBOTT IRELAND
07P6721
In Commercial Distribution

  • 00380740136697 ()
07P6721

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBc Reagent Kit 1200 Tests
Abbott GmbH
07P8431
In Commercial Distribution

  • 00380740136666 ()
07P8431

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBc Reagent Kit 200 Tests
Abbott GmbH
07P8421
In Commercial Distribution

  • 00380740136659 ()
07P8421

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Alinity i HIV Ag/Ab Combo Controls
Abbott GmbH
08P0712
In Commercial Distribution

  • 00380740136574 ()
08P0712

  • HIV1/HIV2 antigen/antibody IVD, control
Alinity i Folate Reagent Kit 200 Tests
ABBOTT IRELAND
08P1421
In Commercial Distribution

  • 00380740136550 ()
08P1421

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Alinity i TSH Reagent Kit 200 Tests
ABBOTT IRELAND
07P4820
In Commercial Distribution

  • 00380740131142 ()
07P4820

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Alinity i FSH Reagent Kit 1200 Tests
ABBOTT IRELAND
07P4930
In Commercial Distribution

  • 00380740131647 ()
07P4930

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Alinity i FSH Reagent Kit 200 Tests
ABBOTT IRELAND
07P4920
In Commercial Distribution

  • 00380740131630 ()
07P4920

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Alinity i T-Uptake Reagent Kit 200 Tests
Abbott Ireland Diagnostics
08P1220
In Commercial Distribution

  • 00380740131548 ()
08P1220

  • Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay
Alinity i Ferritin Reagent Kit 1200 Tests
ABBOTT IRELAND
07P6530
In Commercial Distribution

  • 00380740131487 ()
07P6530

  • Ferritin IVD, kit, chemiluminescent immunoassay
Alinity i Ferritin Reagent Kit 200 Tests
ABBOTT IRELAND
07P6520
In Commercial Distribution

  • 00380740131470 ()
07P6520

  • Ferritin IVD, kit, chemiluminescent immunoassay
Alinity i TSH Reagent Kit 1200 Tests
ABBOTT IRELAND
07P4830
In Commercial Distribution

  • 00380740131159 ()
07P4830

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Alinity i Folate Manual Diluent 1 Tests
ABBOTT IRELAND
08P1460
In Commercial Distribution

  • 00380740130923 ()
08P1460

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Alinity i CEA Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P6230
In Commercial Distribution

  • 00380740130862 ()
07P6230

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Alinity i CEA Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P6220
In Commercial Distribution

  • 00380740130855 ()
07P6220

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Alinity i AFP Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P9030
In Commercial Distribution

  • 00380740130824 ()
07P9030

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Alinity i AFP Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P9020
In Commercial Distribution

  • 00380740130817 ()
07P9020

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
ASHA 2530-01 AMBIENT ARTHOW COVAC 50 I
MEDLINE INDUSTRIES, INC.
ASHA25301RH
In Commercial Distribution

  • 10888277669871 ()
ASHA25301RH

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
UC150 Cleaner Unit AUS Plug Type I
COLTENE/WHALEDENT INC
60021990
In Commercial Distribution

  • D661600219900 ()


  • Ultrasonic-cleaning water bath
7209647 @LIGAMENT CHISEL PRB, CURVED W/I
MEDLINE INDUSTRIES, INC.
7209647RH
In Commercial Distribution

  • 10888277375413 ()
7209647RH

  • Endoscopic electrosurgical electrode, bipolar, reprocessed
Carbide Paro I CA L 1,0 mm
DFS - DIAMON GmbH
113510
In Commercial Distribution

  • 04057176150561 ()
  • 04057176150578 ()


  • Carbide dental bur, reusable
MEDIVEN ANGIO 20-30 PETITE BLACK SIZE I
MEDI MANUFACTURING, INC.
3Y47511
In Commercial Distribution

  • 04061736671410 ()


  • Compression/pressure sock/stocking, single-use
CUSTOM PACK BB6Y28R11 CMAG L I V
MEDTRONIC, INC.
BB6Y28R11
In Commercial Distribution

  • 00199150006861 ()


  • Cardiopulmonary bypass system blood tubing set
Audéo S SMART I (dark cliff gray)
Phonak AG
050-0965-F0
In Commercial Distribution

  • 07613275054048 ()
050-0965-F0

  • Air-conduction hearing aid, receiver-in-canal
Audéo S SMART I (glacier ice gray)
Phonak AG
050-0965-G2
In Commercial Distribution

  • 07613275010082 ()
050-0965-G2

  • Air-conduction hearing aid, receiver-in-canal
Audéo S SMART I (mid cloud gray)
Phonak AG
050-0965-G1
In Commercial Distribution

  • 07613275010075 ()
050-0965-G1

  • Air-conduction hearing aid, receiver-in-canal
Eyeglass Frame,"I Heart You,Plum,49"
ENCORE VISION, INC.
I Heart You
In Commercial Distribution

  • 00812056032818 ()


  • Prescription spectacles
Replacement back end for Simcoe I/A
Psi/Eye-Ko, Inc.
3003BR
In Commercial Distribution

  • 00840516120232 ()
  • 00840516116310 ()
  • 00840516124100 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Replacement back end for Simcoe I/A
Psi/Eye-Ko, Inc.
3003BR
In Commercial Distribution

  • 00840516104959 ()
  • 00840516113395 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
NEBULIZER W/TEE & TUBING, SMALL VOLUME I
TELEFLEX INCORPORATED
IPN044481
In Commercial Distribution

  • 24026704390605 ()
  • 04026704390601 ()
  • 14026704390608 ()
41891

  • Benchtop nebulizer, non-heated
ALGINATE ESSENTIALS ALL PURPOSE TYPE I 1LB
MDC DENTAL
ESSENTIALS
In Commercial Distribution

  • 07506338321631 ()


  • Alginate dental impression material
MAX PRINT ALL PURPOSE TYPE I 454GR
MDC DENTAL
Max print
In Commercial Distribution

  • 07506338315159 ()


  • Alginate dental impression material
MAX PRINT CHROMATIC TYPE I SAMPLE 21GR
MDC DENTAL
Max Print Cromático
In Commercial Distribution

  • 07506338315029 ()


  • Alginate dental impression material
MAX PRINT CYAN ALGINATE TYPE I 454GR
MDC DENTAL
Max Print Cyan
In Commercial Distribution

  • 07506338303514 ()


  • Alginate dental impression material
EMPTY SCFE IMPLANT & INSTRUMENT CASE - GENERATION I
Orthopediatrics Canada ULC
SCF-CSE100
In Commercial Distribution

  • 07540194008046 ()
SCF-CSE100

  • Surgical instrument/implant rack
2.0MP LEFORT I PLATE,3MM ADVANCEMENT,R
Stryker Leibinger GmbH & Co. KG
92-12203
In Commercial Distribution

  • 07613252254041 ()

  • Number of Screw Holes: 10.0 Holes
  • Bar Length: 3.0 Millimeter
92-12203

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
2.0MP LEFORT I PLATE,2MM ADVANCEMENT,R
Stryker Leibinger GmbH & Co. KG
92-12202
In Commercial Distribution

  • 07613252254034 ()

  • Bar Length: 2.0 Millimeter
  • Number of Screw Holes: 10.0 Holes
92-12202

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
2.0MP LEFORT I PLATE,2MM ADVANCEMENT,L
Stryker Leibinger GmbH & Co. KG
92-11202
In Commercial Distribution

  • 07613252254027 ()

  • Number of Screw Holes: 10.0 Holes
  • Bar Length: 2.0 Millimeter
92-11202

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
2.0MP LEFORT I PLATE,3MM ADVANCEMENT,L
Stryker Leibinger GmbH & Co. KG
92-11203
In Commercial Distribution

  • 07613252254010 ()

  • Number of Screw Holes: 10.0 Holes
  • Bar Length: 3.0 Millimeter
92-11203

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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