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 s HTLV I/II Assay Control Kit
Abbott GmbH
06P0720
In Commercial Distribution

  • 00380740167493 ()
06P0720

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control
Alinity i HBsAg Next Confirmatory Reagent Kit (200T)
Abbott Ireland Diagnostics
01R6521
In Commercial Distribution

  • 00380740161262 ()
01R6521

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Alinity i Total B-hCG Reagent Kit 1200 Tests
ABBOTT IRELAND
07P5131
In Commercial Distribution

  • 00380740160623 ()
07P5131

  • Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay
Alinity i Free PSA Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P9321
In Commercial Distribution

  • 00380740158330 ()
07P9321

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Alinity i Total PSA Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P9221
In Commercial Distribution

  • 00380740158316 ()
07P9221

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Alinity i BRAHMS PCT Reagent Kit 200 Tests
Abbott Ireland Diagnostics
01R1821
In Commercial Distribution

  • 00380740153953 ()
01R1821

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
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 200 Tests
Abbott GmbH
07P6021
In Commercial Distribution

  • 00380740138196 ()
07P6021

  • Treponema pallidum total antibody 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 200 Tests
ABBOTT IRELAND
07P6920
In Commercial Distribution

  • 00380740131104 ()
07P6920

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Vial Qc Antigen Sal O Group I 1Ml
BECTON, DICKINSON AND COMPANY
211757
Not in Commercial Distribution

  • 00382902117575 ()

  • Total Volume: 1 Milliliter
211757

  • Multiple Salmonella species antigen IVD, control
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
!SP 30-40 PLUS MAT PANTY CT BLK I
MEDI MANUFACTURING, INC.
24351
In Commercial Distribution

  • 00636257158135 ()


  • Compression/pressure sock/stocking, single-use
!SP 20-30 PLUS MAT PANTY CT BLK I
MEDI MANUFACTURING, INC.
22951
In Commercial Distribution

  • 00636257157923 ()


  • Compression/pressure sock/stocking, single-use
!SP 30-40 PLUS PANTY PET CT BLK I
MEDI MANUFACTURING, INC.
28451
In Commercial Distribution

  • 00636257157855 ()


  • Compression/pressure sock/stocking, single-use
!SP 20-30 PLUS PANTY PET CT BLK I
MEDI MANUFACTURING, INC.
11251
In Commercial Distribution

  • 00636257157572 ()


  • Compression/pressure sock/stocking, single-use
30-40 MFW VITALITY CALF PET CT CHOC I
MEDI MANUFACTURING, INC.
D247931
In Commercial Distribution

  • 00636257142684 ()


  • Compression/pressure sock/stocking, single-use
20-30 MFW VITALITY CALF PET CT CHOC I
MEDI MANUFACTURING, INC.
D147931
In Commercial Distribution

  • 00636257142547 ()


  • Compression/pressure sock/stocking, single-use
15-20 MFW VITALITY CALF PET CT CHOC I
MEDI MANUFACTURING, INC.
D047931
In Commercial Distribution

  • 00636257142400 ()


  • Compression/pressure sock/stocking, single-use
30-40 MFW VITALITY CALF PET CT EBONY I
MEDI MANUFACTURING, INC.
D247531
In Commercial Distribution

  • 00636257142264 ()


  • Compression/pressure sock/stocking, single-use
30-40 MFW VITALITY CALF PET CT CHARC I
MEDI MANUFACTURING, INC.
D247431
In Commercial Distribution

  • 00636257142196 ()


  • Compression/pressure sock/stocking, single-use
20-30 MFW VITALITY CALF PET CT EBONY I
MEDI MANUFACTURING, INC.
D147531
In Commercial Distribution

  • 00636257141816 ()


  • Compression/pressure sock/stocking, single-use
20-30 MFW VITALITY CALF PET CT CHARC I
MEDI MANUFACTURING, INC.
D147431
In Commercial Distribution

  • 00636257141748 ()


  • Compression/pressure sock/stocking, single-use
15-20 MFW VITALITY CALF PET CT EBONY I
MEDI MANUFACTURING, INC.
D047531
In Commercial Distribution

  • 00636257141359 ()


  • Compression/pressure sock/stocking, single-use
15-20 MFW VITALITY CALF PET CT CHARC I
MEDI MANUFACTURING, INC.
D047431
In Commercial Distribution

  • 00636257141281 ()


  • Compression/pressure sock/stocking, single-use
30-40 SHEER&SOFT THIGH TB CT CHARC I
MEDI MANUFACTURING, INC.
43841
In Commercial Distribution

  • 00636257140895 ()


  • Compression/pressure sock/stocking, single-use
20-30 SHEER&SOFT THIGH TB CT CHARC I
MEDI MANUFACTURING, INC.
43241
In Commercial Distribution

  • 00636257140680 ()


  • Compression/pressure sock/stocking, single-use
15-20 SHEER&SOFT THIGH TB CT CHARC I
MEDI MANUFACTURING, INC.
42641
In Commercial Distribution

  • 00636257140475 ()


  • Compression/pressure sock/stocking, single-use
30-40 COMF THG LACE TB CT CHOCOLATE I
MEDI MANUFACTURING, INC.
48791
In Commercial Distribution

  • 00636257140338 ()


  • Compression/pressure sock/stocking, single-use
15-20 COMF THG LACE TB CT CHOCOLATE I
MEDI MANUFACTURING, INC.
44991
In Commercial Distribution

  • 00636257139677 ()


  • Compression/pressure sock/stocking, single-use
30-40 COMFORT CALF PET CT NAVY I S
MEDI MANUFACTURING, INC.
482S31
In Commercial Distribution

  • 00636257063590 ()


  • Compression/pressure sock/stocking, single-use
30-40 COMFORT CALF PET CT SANDSTONE I S
MEDI MANUFACTURING, INC.
482S11
In Commercial Distribution

  • 00636257063521 ()


  • Compression/pressure sock/stocking, single-use
30-40 COMFORT CALF PET CT NATURAL I S
MEDI MANUFACTURING, INC.
482S01
In Commercial Distribution

  • 00636257063453 ()


  • Compression/pressure sock/stocking, single-use
COMFORT 15-20 CALF BDTB OT EBONY I S
MEDI MANUFACTURING, INC.
47WS51
In Commercial Distribution

  • 00636257062968 ()


  • Compression/pressure sock/stocking, single-use
COMFORT 15-20 CALF BDTB OT NAT I S
MEDI MANUFACTURING, INC.
47WS01
In Commercial Distribution

  • 00636257062890 ()


  • Compression/pressure sock/stocking, single-use
20-30 COMFORT CALF PET OT EBONY I S
MEDI MANUFACTURING, INC.
474S51
In Commercial Distribution

  • 00636257062135 ()


  • Compression/pressure sock/stocking, single-use
20-30 COMFORT CALF PET OT SANDSTONE I S
MEDI MANUFACTURING, INC.
474S11
In Commercial Distribution

  • 00636257062067 ()


  • Compression/pressure sock/stocking, single-use
20-30 COMFORT CALF PET OT NATURAL I S
MEDI MANUFACTURING, INC.
474S01
In Commercial Distribution

  • 00636257061992 ()


  • Compression/pressure sock/stocking, single-use
20-30 COMFORT THIGH PET CT NATURAL I S
MEDI MANUFACTURING, INC.
466S01
In Commercial Distribution

  • 00636257060605 ()


  • Compression/pressure sock/stocking, single-use
20-30 COMFORT CALF PET CT CHOCOLATE I S
MEDI MANUFACTURING, INC.
462S91
In Commercial Distribution

  • 00636257060261 ()


  • Compression/pressure sock/stocking, single-use
20-30 COMFORT CALF PET CT WHEAT I S
MEDI MANUFACTURING, INC.
462S81
In Commercial Distribution

  • 00636257060193 ()


  • Compression/pressure sock/stocking, single-use
20-30 COMFORT CALF PET CT EBONY I S
MEDI MANUFACTURING, INC.
462S51
In Commercial Distribution

  • 00636257060124 ()


  • Compression/pressure sock/stocking, single-use
20-30 COMFORT CALF PET CT NAVY I S
MEDI MANUFACTURING, INC.
462S31
In Commercial Distribution

  • 00636257060056 ()


  • Compression/pressure sock/stocking, single-use
20-30 COMFORT CALF PET CT SANDSTONE I S
MEDI MANUFACTURING, INC.
462S11
In Commercial Distribution

  • 00636257059982 ()


  • Compression/pressure sock/stocking, single-use
COMFORT 30-40 CALF BDTB CT EBONY I S
MEDI MANUFACTURING, INC.
45WS51
In Commercial Distribution

  • 00636257059562 ()


  • Compression/pressure sock/stocking, single-use
COMFORT 30-40 CALF BDTB CT NAT I S
MEDI MANUFACTURING, INC.
45WS01
In Commercial Distribution

  • 00636257059494 ()


  • Compression/pressure sock/stocking, single-use
15-20 COMFORT CALF PET OT WHEAT I S
MEDI MANUFACTURING, INC.
456S81
In Commercial Distribution

  • 00636257058862 ()


  • Compression/pressure sock/stocking, single-use
15-20 COMFORT CALF PET OT EBONY I S
MEDI MANUFACTURING, INC.
456S51
In Commercial Distribution

  • 00636257058794 ()


  • Compression/pressure sock/stocking, single-use
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