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 Assay File
Abbott GmbH
09P261A
In Commercial Distribution

  • 00380740151409 ()
09P261A

  • Laboratory instrument/analyser application software IVD
Alinity i Testo 2G Assay File
Abbott GmbH
07P683A
In Commercial Distribution

  • 00380740150914 ()
07P683A

  • Laboratory instrument/analyser application software IVD
Alinity i iPTH Stat Assay File
Abbott GmbH
08P313A
In Commercial Distribution

  • 00380740146665 ()
08P313A

  • Laboratory instrument/analyser application software IVD
Alinity i CA 15-3 Assay File
Abbott GmbH
08P511A
In Commercial Distribution

  • 00380740146597 ()
08P511A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAg Qualitative II Controls
Abbott Ireland Diagnostics
08P1012
In Commercial Distribution

  • 00380740146245 ()
08P1012

  • Hepatitis B virus surface antigen IVD, control
Alinity i 25-OH Vitamin D Controls
ABBOTT IRELAND
08P4512
In Commercial Distribution

  • 00380740146221 ()
08P4512

  • Multiple form 25-hydroxy Vitamin D IVD, control
Alinity i Free PSA Assay File
Abbott GmbH
07P931A
In Commercial Distribution

  • 00380740142858 ()
07P931A

  • Laboratory instrument/analyser application software IVD
Alinity i Total T4 Assay File
Abbott GmbH
07P951A
In Commercial Distribution

  • 00380740142797 ()
07P951A

  • Laboratory instrument/analyser application software IVD
Alinity i Free T4 Assay File
Abbott GmbH
07P701A
In Commercial Distribution

  • 00380740142766 ()
07P701A

  • Laboratory instrument/analyser application software IVD
Alinity i CA 125 II Controls
Abbott GmbH
08P4910
In Commercial Distribution

  • 00380740135508 ()
08P4910

  • Cancer antigen 125 (CA125) IVD, control
Alinity i CA 125 II Calibrators
Abbott GmbH
08P4901
In Commercial Distribution

  • 00380740131036 ()
08P4901

  • Cancer antigen 125 (CA125) IVD, calibrator
Alinity i HBsAg Next Qualitative Controls
Abbott Ireland Diagnostics
01R6412
In Commercial Distribution

  • 00380740214302 ()
01R6412

  • Hepatitis B virus surface antigen IVD, control
Alinity i HBsAg Next Qualitative Calibrators
Abbott Ireland Diagnostics
01R6402
In Commercial Distribution

  • 00380740214296 ()
01R6402

  • Hepatitis B virus surface antigen IVD, calibrator
Alinity i HBsAgNx_%N Assay File
Abbott GmbH
01R657A
In Commercial Distribution

  • 00380740202897 ()
01R657A

  • Laboratory instrument/analyser application software IVD
Alinity i Toxo IgM Assay File
Abbott GmbH
07P475A
In Commercial Distribution

  • 00380740201982 ()
07P475A

  • Laboratory instrument/analyser application software IVD
Alinity i Free T4 Assay File
Abbott GmbH
07P701C
In Commercial Distribution

  • 00380740195458 ()
07P701C

  • Laboratory instrument/analyser application software IVD
Alinity i HSV-1 IgG Assay File
Abbott GmbH
04W201A
In Commercial Distribution

  • 00380740194758 ()
04W201A

  • Laboratory instrument/analyser application software IVD
Alinity i COV 2IgGII Assay File
Abbott GmbH
06S611A
In Commercial Distribution

  • 00380740194093 ()
06S611A

  • Laboratory instrument/analyser application software IVD
Alinity i STAT High Sensitivity Tropopnin-I
Abbott GmbH
04Z211A
In Commercial Distribution

  • 00380740193638 ()
04Z211A

  • Laboratory instrument/analyser application software IVD
Alinity i Free T4 Assay File
Abbott GmbH
07P701B
In Commercial Distribution

  • 00380740193577 ()
07P701B

  • Laboratory instrument/analyser application software IVD
Alinity i COV-2 IgM Assay File
Abbott GmbH
06R911A
In Commercial Distribution

  • 00380740192464 ()
06R911A

  • Laboratory instrument/analyser application software IVD
Alinity i COV-2 IgG Assay File
Abbott GmbH
06R901A
In Commercial Distribution

  • 00380740192457 ()
06R901A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM - US
ABBOTT LABORATORIES
04P5522
In Commercial Distribution

  • 00380740192372 ()
04P5522

  • Laboratory instrument/analyser application software IVD
Alinity i Active B12 Assay File
Abbott GmbH
09P261B
In Commercial Distribution

  • 00380740185787 ()
09P261B

  • Laboratory instrument/analyser application software IVD
Anterior shade I, mould A73, L
The Myerson Company Limited
T600IL0A73
In Commercial Distribution

  • 00842326148147 ()


  • Resin artificial teeth
Anterior shade I, mould A63, L
The Myerson Company Limited
T600IL0A63
In Commercial Distribution

  • 00842326148123 ()


  • Resin artificial teeth
Anterior shade I, mould 13, L
The Myerson Company Limited
T600IL0013
In Commercial Distribution

  • 00842326148086 ()


  • Resin artificial teeth
Anterior shade I, mould 11, L
The Myerson Company Limited
T600IL0011
In Commercial Distribution

  • 00842326148062 ()


  • Resin artificial teeth
Anterior shade I, mould 8, L
The Myerson Company Limited
T600IL0008
In Commercial Distribution

  • 00842326148048 ()


  • Resin artificial teeth
Anterior shade I, mould 7, L
The Myerson Company Limited
T600IL0007
In Commercial Distribution

  • 00842326148031 ()


  • Resin artificial teeth
Anterior shade I, mould 3, L
The Myerson Company Limited
T600IL0003
In Commercial Distribution

  • 00842326148024 ()


  • Resin artificial teeth
Anterior shade I, mould YW3, U
The Myerson Company Limited
T600IU0YW3
In Commercial Distribution

  • 00842326148000 ()


  • Resin artificial teeth
Anterior shade I, mould YM3, U
The Myerson Company Limited
T600IU0YM3
In Commercial Distribution

  • 00842326147980 ()


  • Resin artificial teeth
Anterior shade I, mould A52, U
The Myerson Company Limited
T600IU0A52
In Commercial Distribution

  • 00842326147942 ()


  • Resin artificial teeth
Anterior shade I, mould A44, U
The Myerson Company Limited
T600IU0A44
In Commercial Distribution

  • 00842326147935 ()


  • Resin artificial teeth
Anterior shade I, mould A11, U
The Myerson Company Limited
T600IU0A11
In Commercial Distribution

  • 00842326147904 ()


  • Resin artificial teeth
Anterior shade I, mould A9, U
The Myerson Company Limited
T600IU00A9
In Commercial Distribution

  • 00842326147898 ()


  • Resin artificial teeth
Anterior shade I, mould A4, U
The Myerson Company Limited
T600IU00A4
In Commercial Distribution

  • 00842326147874 ()


  • Resin artificial teeth
Alinity i 25-OH Vitamin D Calibrators
ABBOTT IRELAND
08P4501
In Commercial Distribution

  • 00380740121907 ()
08P4501

  • Multiple form 25-hydroxy Vitamin D IVD, calibrator
Alinity i 2nd Generation Testosterone Calibrators
Abbott GmbH
07P6801
In Commercial Distribution

  • 00380740130343 ()
07P6801

  • Total testosterone IVD, calibrator
AnyPlus I ACIF PEEK Cage Tray
GS Medical Co., Ltd.
GS136-9410
In Commercial Distribution

  • 08806162109498 ()
GS136-9410

  • Instrument tray, reusable
Cam I Joint 1/2x3/8in
THOMPSON SURGICAL INSTRUMENTS, INC.
42125OC
In Commercial Distribution

  • 00841536107982 ()


  • Surgical retraction system, reusable
Cam I Joint 1/2x1/4in
THOMPSON SURGICAL INSTRUMENTS, INC.
42125C
In Commercial Distribution

  • 00841536107968 ()


  • Surgical retraction system, reusable
Cam I Joint 1/4x1/4in
THOMPSON SURGICAL INSTRUMENTS, INC.
42124C
In Commercial Distribution

  • 00841536107951 ()


  • Surgical retraction system, reusable
Cam I Joint 1/2x1/2in
THOMPSON SURGICAL INSTRUMENTS, INC.
42110C
In Commercial Distribution

  • 00841536107791 ()


  • Surgical retraction system, reusable
Elite I RC w/1 Jnt
THOMPSON SURGICAL INSTRUMENTS, INC.
41902A
In Commercial Distribution

  • 00841536107562 ()


  • Self-retaining surgical retractor, reusable
Elite I RC w/1 Clamp
THOMPSON SURGICAL INSTRUMENTS, INC.
41900A
In Commercial Distribution

  • 00841536107333 ()


  • Self-retaining surgical retractor, reusable
SET SCREW FIRST DRIVER I HANDLE
L&K BIOMED CO. ,LTD.
LS05-0623
In Commercial Distribution

  • 08800108689402 ()
LS05-0623

  • Surgical screwdriver, reusable
MODULAR I HANDLE 1/4 SQUARE
L&K BIOMED CO. ,LTD.
PT01-0012
In Commercial Distribution

  • 08800108696929 ()
PT01-0012

  • Orthopaedic prosthesis implantation positioning instrument, reusable
LEVAMED STABILI-TRI ANK BLU R I
MEDI MANUFACTURING, INC.
K012331
In Commercial Distribution

  • 04047872673174 ()


  • Ankle/foot orthosis
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