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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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Acucy System - 00742860100338

No Description
SEKISUI DIAGNOSTICS, LLC
1039
Not in Commercial Distribution

  • 00742860100338 ()


  • Photometric/spectroscopic immunoassay analyser IVD

OSOM Ultra Flu Aspirate 25T Kit - 00742860100239

OSOM Ultra Flu Aspirate 25T Kit
SEKISUI DIAGNOSTICS, LLC
1007
In Commercial Distribution

  • 00742860100239 ()
  • 10742860100236 ()
1007

  • Nasopharyngeal aspirate container IVD

BD Veritor™ System CLIA-Waived Combo Pack - 00382902560715

BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055)
BECTON, DICKINSON AND COMPANY
256071
Not in Commercial Distribution

  • 00382902560715 ()
256071

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical

Silaris Dock - B54010260

The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
1026
In Commercial Distribution

  • B54010260 ()
1026

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

SCISSORS OPERATING 6" CRV. B/B TC - D9283001060

No Description
W.H. Holden, Inc.
30-0106
In Commercial Distribution

  • D9283001060 ()


  • Dental surgical scissors

SCISSORS OPERATING 6" STR B/B TC - D9283001030

No Description
W.H. Holden, Inc.
30-0103
In Commercial Distribution

  • D9283001030 ()


  • Dental surgical scissors

CARDINAL HEALTH - 10195594512439

OPEN HEART PACK B ILM
Cardinal Health 200, LLC
SCVCGOHIL4
In Commercial Distribution

  • 50195594512437 ()
  • 10195594512439 ()
SCVCGOHIL4

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327685362

TOTAL KNEE A & B PACK
MEDLINE INDUSTRIES, INC.
DYNJ86860
In Commercial Distribution

  • 40195327685363 ()
  • 10195327685362 ()
DYNJ86860

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327685355

TOTAL HIP PACK A & B
MEDLINE INDUSTRIES, INC.
DYNJ86861
In Commercial Distribution

  • 10195327685355 ()
DYNJ86861

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594485870

FREE FLAP CUSTOM PACK B
Cardinal Health 200, LLC
SOP56FBUU7
In Commercial Distribution

  • 50195594485878 ()
  • 10195594485870 ()
SOP56FBUU7

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594491888

VAG DELIVERY B MHHS STD
Cardinal Health 200, LLC
SMAMHVBBH1
In Commercial Distribution

  • 50195594491886 ()
  • 10195594491888 ()
SMAMHVBBH1

  • Obstetrical/gynaecological surgical procedure kit, medicated

CARDINAL HEALTH - 10195594497675

KIT, OPEN HEART A B
Cardinal Health 200, LLC
PV33OHADA
In Commercial Distribution

  • 50195594497673 ()
  • 10195594497675 ()
PV33OHADA

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10195594038977

B V CHOL BY LAPAROSCOPY
Cardinal Health 200, LLC
SLC30CLPR4
In Commercial Distribution

  • 50195594038975 ()
  • 10195594038977 ()
SLC30CLPR4

  • Laparoscopic surgical procedure kit, medicated

CARDINAL HEALTH - 10195594033934

OPEN HEART A B PACK
Cardinal Health 200, LLC
SCV33OHAD9
In Commercial Distribution

  • 50195594033932 ()
  • 10195594033934 ()
SCV33OHAD9

  • Cardiothoracic surgical procedure kit, medicated, single-use

Medline Industries, Inc. - 10195327638870

CARDIAC A & B PACKS SMMC
MEDLINE INDUSTRIES, INC.
DYNJ86457
In Commercial Distribution

  • 10195327638870 ()
DYNJ86457

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327623760

TOTAL HIP PACK A&B
MEDLINE INDUSTRIES, INC.
DYNJ46204S
In Commercial Distribution

  • 10195327623760 ()
DYNJ46204S

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327626075

OPEN HEART A AND B
MEDLINE INDUSTRIES, INC.
DYNJ910323
In Commercial Distribution

  • 10195327626075 ()
DYNJ910323

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327651725

FREE FLAP CUSTOM PACK B
MEDLINE INDUSTRIES, INC.
DYNJ82736A
In Commercial Distribution

  • 10195327651725 ()
DYNJ82736A

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327646899

ORTHO SPINE A&B PACK
MEDLINE INDUSTRIES, INC.
DYNJ51835C
In Commercial Distribution

  • 10195327646899 ()
DYNJ51835C

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327648152

OPEN HEART PACK A&B
MEDLINE INDUSTRIES, INC.
DYNJ63100G
In Commercial Distribution

  • 10195327648152 ()
DYNJ63100G

  • General surgical procedure kit, non-medicated, single-use
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