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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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Composi-Tight® - 00810038095370

3D Fusion™ Firm Matrix Band Special Kit: 80 Count (20) FXH100, (10) FXH150, (20) FXH175, (20) FXH200, (10) FXH300
GARRISON DENTAL SOLUTIONS, L.L.C.
FXHB06
In Commercial Distribution

  • 00810038095370 ()
FXHB06

  • Dental matrix band, single-use

Camino® - 10381780023951

The Integra PAC1 cable is intended for use with Camino CAM01 and MPM monitors and Camino Flex catheter products to support the direct and continuous measurement of intracranial pressure (ICP) and intracranial temperature (ICT) when connected to the MPM or Camino CAM01 intracranial pressure ICP monitor. The device is a reusable product.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
PAC1
Not in Commercial Distribution

  • M273PAC11 ()
  • 10381780023951 ()


  • Electrical-only medical device connection cable, reusable

Camino® - 10381780039563

Camino® Single Parameter Monitoring Cable
INTEGRA LIFESCIENCES (IRELAND) LIMITED
PAC2
Not in Commercial Distribution

  • M273PAC21 ()
  • 10381780039563 ()
PAC2

  • Electrical-only medical device connection cable, reusable

ZYM A - 03573026142001

ZYM A is a reagent associated to API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200)
BIOMERIEUX SA
70494
In Commercial Distribution

  • 03573026142001 ()


  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit

3Shape Scan Bodies - 05902729751452

Camlog - Screwdriver
3shape Trios A/S
CC
In Commercial Distribution

  • 05902729751452 ()


  • Dental milling system, CAD/CAM, laboratory

Advance Dental Products - 00371347019568

Precision Series Ortho Stops, Closed
The Atlanta Dental Supply Company
CC
In Commercial Distribution

  • 10371347019565 ()
  • 00371347019568 ()


  • Orthodontic lock

Continum C - 10852187007276

Continum C, Dental casting non-noble alloy
AALBA DENT INC.
CC
In Commercial Distribution

  • 10852187007276 ()


  • Dental casting non-noble alloy

Continum C - 90852187007067

Continum C, Dental casting non-noble alloy
AALBA DENT INC.
CC
In Commercial Distribution

  • 90852187007067 ()


  • Dental casting non-noble alloy

Face a Face - 03663524273533

No Description
Design Eyewear Group International A/S
FFBOCCAPIXIES2/1946
In Commercial Distribution

  • 03663524273533 ()


  • Tinted non-prescription spectacles

NIAGARA® Lateral Access System - 10888857488731

Intradiscal Shim, Size 20 mm
K2M, INC.
SP-4220-01
In Commercial Distribution

  • 10888857488731 ()

  • Length: 20 Millimeter
SP-4220-01

  • Surgical retractor/retraction system blade, reusable
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