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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Alinity i Active-B12 (Holotranscobalamin) Reagent Kit 200 Tests
Abbott GmbH
09P2620
In Commercial Distribution

  • 00380740150525 ()
09P2620

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Alinity i Syphilis TP Reagent Kit 1200 Tests
Abbott GmbH
07P6031
In Commercial Distribution

  • 00380740138332 ()
07P6031

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Syphilis TP Reagent Kit 200 Tests
Abbott GmbH
07P6021
In Commercial Distribution

  • 00380740138196 ()
07P6021

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Total T4 Reagent Kit 1200 Tests
ABBOTT IRELAND
07P9530
In Commercial Distribution

  • 00380740131524 ()
07P9530

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Alinity i Total T4 Reagent Kit 200 Tests
ABBOTT IRELAND
07P9520
In Commercial Distribution

  • 00380740131517 ()
07P9520

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Alinity i CA 15-3 Reagent Kit 200 Tests
Abbott GmbH
08P5120
In Commercial Distribution

  • 00380740131432 ()
08P5120

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Alinity i HAVAb IgG Reagent Kit 200 Tests
Abbott GmbH
08P2721
In Commercial Distribution

  • 00380740131371 ()
08P2721

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Alinity i Free T3 Reagent Kit 1200 Tests
ABBOTT IRELAND
07P6930
In Commercial Distribution

  • 00380740131111 ()
07P6930

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Alinity i Free T3 Reagent Kit 200 Tests
ABBOTT IRELAND
07P6920
In Commercial Distribution

  • 00380740131104 ()
07P6920

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Alinity i HAVAb IgM Reagent Kit 1000 Tests
Abbott GmbH
08P2831
In Commercial Distribution

  • 00380740136628 ()
08P2831

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alinity i HAVAb IgM Reagent Kit 200 Tests
Abbott GmbH
08P2821
In Commercial Distribution

  • 00380740136611 ()
08P2821

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alinity i Intact PTH Reagent Kit 200 Tests
Abbott GmbH
08P3121
In Commercial Distribution

  • 00380740136215 ()
08P3121

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Alinity i CA 15-3 Reagent Kit 1000 Tests
Abbott GmbH
08P5130
In Commercial Distribution

  • 00380740131449 ()
08P5130

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Alcon Intrepid 0.3mm Polymer I/A Bimanual Set
Alcon Laboratories, Inc.
8065751922
In Commercial Distribution

  • 10380657519221 ()
  • 00380657519224 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Alcon Intrepid Curved 0.3mm Polymer I/A Tip
Alcon Laboratories, Inc.
8065751512
In Commercial Distribution

  • 10380657515124 ()
  • 00380657515127 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Alcon Intrepid Angled 0.3mm Polymer I/A Tip
Alcon Laboratories, Inc.
8065751511
In Commercial Distribution

  • 10380657515117 ()
  • 00380657515110 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Alcon Intrepid Straight 0.3mm Polymer I/A Tip
Alcon Laboratories, Inc.
8065751510
In Commercial Distribution

  • 10380657515100 ()
  • 00380657515103 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Medviron Huron Bassinet, I drawer with standard pull.
MEDVIRON LLC
Single Drawer
In Commercial Distribution

  • 10851477007033 ()
M13-0000-0000

  • Infant-hammock bed mattress
Natural I SS L .020/.51 (1/10PKS)
World Class Technology Corporation
61.40.280.00020
In Commercial Distribution

  • 00840273912347 ()
61.40.280.00020

  • Orthodontic archwire
Natural I SS L .018/.46 (1/10PKS)
World Class Technology Corporation
61.40.280.00018
In Commercial Distribution

  • 00840273912330 ()
61.40.280.00018

  • Orthodontic archwire
Natural I SS L .016/.41 (1/10PKS)
World Class Technology Corporation
61.40.280.00016
In Commercial Distribution

  • 00840273912323 ()
61.40.280.00016

  • Orthodontic archwire
Natural I SS L .014/.36 (1/10PKS)
World Class Technology Corporation
61.40.280.00014
In Commercial Distribution

  • 00840273912316 ()
61.40.280.00014

  • Orthodontic archwire
Natural I SS L .012/.30 (1/10PKS)
World Class Technology Corporation
61.40.280.00012
In Commercial Distribution

  • 00840273912309 ()
61.40.280.00012

  • Orthodontic archwire
Natural I BT L .018/.46 (1/5PKS)
World Class Technology Corporation
61.40.270.00018
In Commercial Distribution

  • 00840273912231 ()
61.40.270.00018

  • Orthodontic archwire
Natural I BT L .016/.41 (1/5PKS)
World Class Technology Corporation
61.40.270.00016
In Commercial Distribution

  • 00840273912224 ()
61.40.270.00016

  • Orthodontic archwire
Natural I SS U .020/.51 (1/10PKS)
World Class Technology Corporation
61.40.180.00020
In Commercial Distribution

  • 00840273911319 ()
61.40.180.00020

  • Orthodontic archwire
Natural I SS U .018/.46 (1/10PKS)
World Class Technology Corporation
61.40.180.00018
In Commercial Distribution

  • 00840273911302 ()
61.40.180.00018

  • Orthodontic archwire
Natural I SS U .016/.41 (1/10PKS)
World Class Technology Corporation
61.40.180.00016
In Commercial Distribution

  • 00840273911296 ()
61.40.180.00016

  • Orthodontic archwire
Natural I SS U .014/.36 (1/10PKS)
World Class Technology Corporation
61.40.180.00014
In Commercial Distribution

  • 00840273911289 ()
61.40.180.00014

  • Orthodontic wire
Natural I SS U .012/.30 (1/10PKS)
World Class Technology Corporation
61.40.180.00012
In Commercial Distribution

  • 00840273911272 ()
61.40.180.00012

  • Orthodontic archwire
Natural I BT U .018/.46 (1/5PKS)
World Class Technology Corporation
61.40.170.00018
In Commercial Distribution

  • 00840273911203 ()
61.40.170.00018

  • Orthodontic archwire
Natural I BT U .016/.41 (1/5PKS)
World Class Technology Corporation
61.40.170.00016
In Commercial Distribution

  • 00840273911197 ()
61.40.170.00016

  • Orthodontic archwire
DIM Analog Ø 5,0 I 5.DIM.500
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566636837 ()
NT/BB-AW-00/3D

  • Dental implant analog
DIM Analog Ø 3,4 I 5.DIM.340
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566636820 ()
NT/BB-AN-00/3D

  • Dental implant analog
DIM Analog Ø 4,1 I 5.DIM.410
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566636813 ()
NT/BB-AR-00/3D

  • Dental implant analog
Thornton 20° Angled I/A Tip, Stainless Steel
RUMEX INTERNATIONAL CORP.
7-080/20
In Commercial Distribution

  • 00840159904671 ()
7-080/20

  • Surgical irrigation/aspiration handpiece, reusable
Double I/A Cannula 21g/19g, open end
Psi/Eye-Ko, Inc.
3002
In Commercial Distribution

  • 00840516120195 ()
  • 00840516116273 ()
  • 00840516124063 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/21g, open end
Psi/Eye-Ko, Inc.
3001
In Commercial Distribution

  • 00840516120188 ()
  • 00840516116266 ()
  • 00840516124056 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
"J" Shaped Double I/A Cannula 23g/25g
Psi/Eye-Ko, Inc.
3000J
In Commercial Distribution

  • 00840516120171 ()
  • 00840516116259 ()
  • 00840516124049 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/21g, side port
Psi/Eye-Ko, Inc.
3000
In Commercial Distribution

  • 00840516120164 ()
  • 00840516116242 ()
  • 00840516124032 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/19g, open end
Psi/Eye-Ko, Inc.
3002
In Commercial Distribution

  • 00840516104904 ()
  • 00840516108827 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/21g, open end
Psi/Eye-Ko, Inc.
3001
In Commercial Distribution

  • 00840516104898 ()
  • 00840516108810 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
"J" Shaped Double I/A Cannula 23g/25g
Psi/Eye-Ko, Inc.
3000J
In Commercial Distribution

  • 00840516104881 ()
  • 00840516108803 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/21g, side port
Psi/Eye-Ko, Inc.
3000
In Commercial Distribution

  • 00840516104874 ()
  • 00840516108797 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
TRACOE phon assist I with Oxygen Supply Port
Tracoe medical GmbH
REF 650-TO
In Commercial Distribution

  • 04035324012930 ()

  • Connector Compatibility Fits on 15 mm connector
REF 650-TO

  • Tracheostomy tube speech valve
TRACOE phon assist I with Oxygen Supply Port
Tracoe medical GmbH
REF 650-SO
Not in Commercial Distribution

  • 04035324012923 ()

  • Fits to 22 mm adapter


  • Tracheostomy tube speech valve
TRACOE phon assist I with Oxygen Supply Port
Tracoe medical GmbH
REF 650-TO-5
In Commercial Distribution

  • 04035324019151 ()
  • 05701780328418 ()

  • Connector Compatibility Fits on 15 mm connector
REF 650-TO-5

  • Tracheostomy tube speech valve
HSW LIGMAJECT® I 1,8 ML IMPERIAL THREAD
Henke-Sass, Wolf GmbH
2101000100
Not in Commercial Distribution

  • 04035873013006 ()
2101000100

  • Dental anaesthesia syringe, reusable
Nichamin I Quick Chopper Used in Left Hand
Avalign Technologies, Inc.
92-H0349
In Commercial Distribution

  • 00190776203375 ()


  • Ophthalmic surgical probe, reusable
Micro Injection Needle Asp I G Str LL
Avalign Technologies, Inc.
39-MINASPI1615LL
In Commercial Distribution

  • 00190776195489 ()


  • Body aspiration needle, reusable
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