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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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GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device
BAXTER HEALTHCARE CORPORATION
1501341
Not in Commercial Distribution

  • 50085412086304 ()
  • 00085412086309 ()
1501341

  • Collagen haemostatic agent, non-antimicrobial
Adherus AutoSpray Dural Sealant is a sterile, single-use, electromechanical, battery operated, device with internal system components that provide air flow to aid in the delivery of a synthetic, absorbable, two-component hydrogel sealant system and allow delivery to be interrupted without clogging.
HYPERBRANCH MEDICAL TECHNOLOGY, INC.
NUS-106
In Commercial Distribution

  • 00897146002018 ()
  • 30897146002019 ()


  • Dura mater sealant
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228043560 ()
874721

  • Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, PROPAQ MD
Zoll Medical Corporation
300-1011301-01
In Commercial Distribution

  • 00847946017644 ()

  • 8.9" x 10.4" x 7.9"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN, R SERIES, PLUS, NELLCOR, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, ETCO2, NIBP, CF/USB, DMST
Zoll Medical Corporation
30001007201310013
In Commercial Distribution

  • 00847946017620 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN, R SERIES, PLUS, 3/5 LD, STD ECG, AC PWR, NELLCOR, PACE, NIBP, CF/STD, DMST
Zoll Medical Corporation
30001006201330013
In Commercial Distribution

  • 00847946017606 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN, R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, NELLCOR, PACE, NIBP, CF/STD, DMST
Zoll Medical Corporation
30001006201330012
In Commercial Distribution

  • 00847946017590 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN, R SERIES, PLUS, 3/5 LD, STD ECG, AC PWR, NELLCOR, PACE, SPO2, NIBP, DMST
Zoll Medical Corporation
30001006201310013
In Commercial Distribution

  • 00847946017583 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN, R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, NELLCOR, PACE, SPO2, NIBP, DMST
Zoll Medical Corporation
30001006201310012
In Commercial Distribution

  • 00847946017576 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN, R SERIES,NELLCOR, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, NIBP, CF/USB, DMST
Zoll Medical Corporation
30001006001310012
In Commercial Distribution

  • 00847946017569 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
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