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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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Cadence™ - 10381780240532

Cadence Tibial Trial is used to verify proper implant placement and sizing.
Ascension Orthopedics, Inc.
10204111
Not in Commercial Distribution

  • M268102041111 ()
  • 10381780240532 ()

  • Size 1X, R


  • Ankle prosthesis trial, reusable

Cadence™ - 10381780240525

Cadence Tibial Trial is used to verify proper implant placement and sizing.
Ascension Orthopedics, Inc.
10204110
Not in Commercial Distribution

  • M268102041101 ()
  • 10381780240525 ()

  • Size 1, R


  • Surgical implant template, reusable

Cadence™ - 10381780240310

Slap Hammer is used to remove the Talar Trial from the talus.
Ascension Orthopedics, Inc.
10203193
Not in Commercial Distribution

  • M268102031931 ()
  • 10381780240310 ()

  • 8in L; 3in L x 1.75in diameter striker


  • Orthopaedic implant impactor, reusable

Titan™ - 10381780237051

The glenosphere inserter is used to insert the glenosphere into the baseplate.
Ascension Orthopedics, Inc.
HDL096006501
In Commercial Distribution

  • M269HDL0960065011 ()
  • 10381780237051 ()

  • 9.8 in L
HDL-0960-065-01

  • Orthopaedic inorganic implant inserter/extractor, reusable

BACT/ALERT® VIRTUO® - 03573026369774

VIRTUO is a fully automated modular system that performs blood culture testing
BIOMERIEUX , INC.
411661
In Commercial Distribution

  • 03573026369774 ()


  • Blood culture analyser IVD

BACT/ALERT® VIRTUO® - 03573026369767

VIRTUO is a fully automated modular system that performs blood culture testing
BIOMERIEUX , INC.
411660
In Commercial Distribution

  • 03573026369767 ()


  • Blood culture analyser IVD

EHR - 03573026099862

EHR is a reagent associated to API 20 A® (20 300)
BIOMERIEUX SA
70520
In Commercial Distribution

  • 03573026099862 ()


  • Multiple anaerobic bacteria species culture isolate identification IVD, reagent

DG Clean - 08436583730799

DG Clean is a solution for cleaning the probes of Grifols analyzers.
DIAGNOSTIC GRIFOLS SA
213797
In Commercial Distribution

  • 08436583730782 ()
  • 08436583730799 ()
213797

  • Wash/cleaning solution IVD, automated/semi-automated system

PM-750 - 00185098000856

(1) -Infrared Massager Heating Device with Auto Shut-Off - Light Bulb is Included
PRO MEDICAL SUPPLIES, INC.
PM-750
In Commercial Distribution

  • 00185098000856 ()
PM-750

  • Hand-held electric massager

Impla Clean Plastic Implant Instrument Kit - 00014081552204

Set of four double-ended plastic implant instruments. Each instrument is shaped differently.
HAGER WORLDWIDE, INC.
355220
Not in Commercial Distribution

  • 00014081552204 ()


  • Manual dental scaler, reusable
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