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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PRESSURE INJURY I, II, DTI
MEDLINE INDUSTRIES, INC.
DYKM1487A
In Commercial Distribution

  • 10193489666663 ()
DYKM1487A

  • General surgical procedure kit, non-medicated, single-use
OR ANGIOGRAPHY DRAPE I PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0495625L
In Commercial Distribution

  • 10889942071470 ()
DYNJ0495625L

  • General surgical procedure kit, non-medicated, reusable
OPEN HEART PART I PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0373897G
In Commercial Distribution

  • 10889942061778 ()
DYNJ0373897G

  • General surgical procedure kit, non-medicated, reusable
CUSTOM PACK CB2978R1 SUPPORT I
MEDTRONIC, INC.
CB2978R1
In Commercial Distribution

  • 00643169878860 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB9N30R SUPPORT I
MEDTRONIC, INC.
CB9N30R
In Commercial Distribution

  • 00643169873940 ()


  • Cardiopulmonary bypass system blood tubing set
C-Arm Kit Ziehm I (1)
EXACT MEDICAL MANUFACTURING, INC.
E6051
Not in Commercial Distribution

  • 00850031271319 ()
  • 00850031271302 ()
  • 00850031271326 ()


  • Medical equipment/instrument drape, single-use
LP Focus Workst. system, I
Alpine Biomed ApS
9033A082106
Not in Commercial Distribution

  • 05704736018814 ()


  • Neurophysiologic monitoring system
LP Focus Notebook system, I
Alpine Biomed ApS
9033A081106
Not in Commercial Distribution

  • 05704736018807 ()


  • Neurophysiologic monitoring system
MINOR GENERAL I & D PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0282367G
In Commercial Distribution

  • 10889942365791 ()
DYNJ0282367G

  • General surgical procedure kit, non-medicated, reusable
OR ANGIOGRAPHY DRAPE I PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0495625M
In Commercial Distribution

  • 10889942358212 ()
DYNJ0495625M

  • General surgical procedure kit, non-medicated, reusable
OR ANGIOGRAPHY DRAPE I PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0495625O
In Commercial Distribution

  • 10193489782738 ()
  • 40193489782739 ()
DYNJ0495625O

  • General surgical procedure kit, non-medicated, single-use
NON STERILE I&D KIT
MEDLINE INDUSTRIES, INC.
DYKM1438
In Commercial Distribution

  • 10889942529964 ()
  • 40889942529965 ()
DYKM1438

  • General surgical procedure kit, medicated
OPEN HEART PART I PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0373897I
In Commercial Distribution

  • 10889942481637 ()
DYNJ0373897I

  • General surgical procedure kit, non-medicated, reusable
WMC I D PACK LF
MEDLINE INDUSTRIES, INC.
DYNJ50806C
In Commercial Distribution

  • 10889942397242 ()
DYNJ50806C

  • General surgical procedure kit, non-medicated, reusable
TAA MINOR SET-UP I PLUS
MEDLINE INDUSTRIES, INC.
DYNJSG0103
In Commercial Distribution

  • 10889942559541 ()
DYNJSG0103

  • General surgical procedure kit, non-medicated, single-use
STND CLOSURE PACK BASIC I
MEDLINE INDUSTRIES, INC.
DYNJ06368
In Commercial Distribution

  • 10889942554003 ()
  • 40889942554004 ()
DYNJ06368

  • General surgical procedure kit, non-medicated, single-use
I&D KIT - IMF 107669
MEDLINE INDUSTRIES, INC.
DYKM2059
In Commercial Distribution

  • 10193489915891 ()
  • 40193489915892 ()
DYKM2059

  • General surgical procedure kit, non-medicated, single-use
PRESSURE INJURY I II IMF107672
MEDLINE INDUSTRIES, INC.
DYKM2058
In Commercial Distribution

  • 10193489915907 ()
  • 40193489915908 ()
DYKM2058

  • General surgical procedure kit, non-medicated, single-use
DEACONESS OPEN HEART I PACK
MEDLINE INDUSTRIES, INC.
DYNJ53817
In Commercial Distribution

  • 10889942443833 ()
DYNJ53817

  • General surgical procedure kit, non-medicated, single-use
Level I (Abnormal) w/ microscopics
KOVA INTERNATIONAL, INC.
87177E
In Commercial Distribution

  • 00855617006040 ()
87177E

  • Urine sediment IVD, control
KOVA-TROL I 4X60ML HIGH ABNORMAL
KOVA INTERNATIONAL, INC.
87325
In Commercial Distribution

  • 00855617006613 ()
87325

  • Urine sediment IVD, control
MINOR GENERAL I & D PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0282367K
In Commercial Distribution

  • 40195327088737 ()
  • 10195327088736 ()
DYNJ0282367K

  • General surgical procedure kit, non-medicated, single-use
MINOR GENERAL I & D PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0282367J
In Commercial Distribution

  • 10889942867516 ()
DYNJ0282367J

  • General surgical procedure kit, non-medicated, single-use
OPEN HEART PART I PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0373897J
In Commercial Distribution

  • 10889942863709 ()
  • 40889942863700 ()
DYNJ0373897J

  • General surgical procedure kit, non-medicated, single-use
Multiholder PK I DTS, Restoration
LM-Dental
750-756EST
In Commercial Distribution

  • 06438311036403 ()


  • Manual dental burnisher, reusable
Nyström I DTS, Carver, Restoration
LM-Dental
74-75EST
In Commercial Distribution

  • 06438311030746 ()


  • Dental restoration carver, resin
Neoss® Guide - Drill-Hub I
Neoss AB
51160
In Commercial Distribution

  • 05060440332715 ()
51160

  • Fixture/appliance dental drill bit, single-use
ER LAC/I&D TRAY
MEDLINE INDUSTRIES, INC.
DYNDL1094A
In Commercial Distribution

  • 10888277042049 ()
DYNDL1094A

  • General surgical procedure kit, medicated
GENUMEDI PSS BLUE, SIZE I
MEDI MANUFACTURING, INC.
K150301
In Commercial Distribution

  • 04064984699533 ()


  • Knee support orthosis
REMOVALON I DRY PK SINGLE
PREMIER DENTAL PRODUCTS COMPANY
8101998
In Commercial Distribution

  • 00348783003857 ()


  • Medical device disinfection agent
7013-8033 @DIEGO TURBINATOR BLADE, I
MEDLINE INDUSTRIES, INC.
REP104129
In Commercial Distribution

  • 10888277351530 ()

  • Outer Diameter: 2 Millimeter
REP104129

  • Arthroscopic shaver system blade, reprocessed
DOA MC I Control Set
ABBOTT LABORATORIES
3L43-10
In Commercial Distribution

  • 00380740005818 ()
03L4310

  • Multiple drugs of abuse IVD, control
DOA MC I Calibrator 4
ABBOTT LABORATORIES
3L43-04
In Commercial Distribution

  • 00380740005795 ()
03L4304

  • Multiple drugs of abuse IVD, calibrator
DOA MC I Calibrator 3
ABBOTT LABORATORIES
3L43-03
In Commercial Distribution

  • 00380740005788 ()
03L4303

  • Multiple drugs of abuse IVD, calibrator
DOA MC I Calibrator 2
ABBOTT LABORATORIES
3L43-02
In Commercial Distribution

  • 00380740005771 ()
03L4302

  • Multiple drugs of abuse IVD, calibrator
DOA MC I Calibrator 1
ABBOTT LABORATORIES
3L43-01
In Commercial Distribution

  • 00380740005764 ()
03L4301

  • Multiple drugs of abuse IVD, calibrator
ULTRAFLOW II I/A HANDPIECE
Alcon Laboratories, Inc.
8065751795
In Commercial Distribution

  • 00380657517954 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Alinity i Total T3 Calibrators
ABBOTT IRELAND
07P9401
In Commercial Distribution

  • 00380740130541 ()
07P9401

  • Total triiodothyronine (TT3) IVD, calibrator
Alinity i CA 19-9XR Calibrators
Abbott GmbH
08P3201
In Commercial Distribution

  • 00380740130510 ()
08P3201

  • Cancer antigen 19-9 (CA19-9) IVD, calibrator
Alinity i Total PSA Controls
Abbott Ireland Diagnostics
07P9210
In Commercial Distribution

  • 00380740130428 ()
07P9210

  • Total prostate specific antigen (tPSA) IVD, control
Alinity i Total PSA Calibrators
Abbott Ireland Diagnostics
07P9201
In Commercial Distribution

  • 00380740130411 ()
07P9201

  • Total prostate specific antigen (tPSA) IVD, calibrator
Alinity i Free PSA Controls
Abbott Ireland Diagnostics
07P9310
In Commercial Distribution

  • 00380740130312 ()
07P9310

  • Free (unbound) prostate specific antigen (fPSA) IVD, control
Alinity i Free PSA Calibrators
Abbott Ireland Diagnostics
07P9301
In Commercial Distribution

  • 00380740130305 ()
07P9301

  • Free (unbound) prostate specific antigen (fPSA) IVD, calibrator
Alinity i Free T4 Controls
ABBOTT IRELAND
07P7010
In Commercial Distribution

  • 00380740121808 ()
07P7010

  • Free thyroxine (FT4) IVD, control
Alinity i Free T4 Calibrators
ABBOTT IRELAND
07P7001
In Commercial Distribution

  • 00380740121792 ()
07P7001

  • Free thyroxine (FT4) IVD, calibrator
Alinity i Syphilis TP Controls
Abbott GmbH
07P6010
In Commercial Distribution

  • 00380740121631 ()
07P6010

  • Treponema pallidum total antibody IVD, control
Alinity i Syphilis TP Calibrator
Abbott GmbH
07P6001
In Commercial Distribution

  • 00380740121624 ()
07P6001

  • Treponema pallidum total antibody IVD, calibrator
Alinity i Total B-hCG Controls
ABBOTT IRELAND
07P5110
In Commercial Distribution

  • 00380740121495 ()
07P5110

  • Human chorionic gonadotropin beta-core fragment IVD, control
Alinity i Total B-hCG Calibrators
ABBOTT IRELAND
07P5101
In Commercial Distribution

  • 00380740121488 ()
07P5101

  • Human chorionic gonadotropin beta-core fragment IVD, calibrator
Alinity i CMV IgG Calibrators
Abbott Ireland Diagnostics
07P4202
In Commercial Distribution

  • 00380740180966 ()
07P4202

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, calibrator
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