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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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ISPAN Perfluoropropane (C3F8) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum), and perfluoropropene 10 ppm (maximum).
ESCALON MEDICAL CORP.
20 g Cylinder
In Commercial Distribution

  • 10860113000109 ()
  • 00860113000102 ()
  • 20860113000106 ()
TR9089

  • Vitreous/aqueous humour replacement medium, intraoperative
Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 International Units)
PHARMACIA & UPJOHN COMPANY LLC
1 g Powder
In Commercial Distribution

  • 00360793410104 ()


  • General surgical procedure kit, medicated
No Description
Biomet Orthopedics, LLC
010000667
In Commercial Distribution

  • 00880304524262 ()

  • 60 mm Shell Size Liner Size G
010000667

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
010000666
In Commercial Distribution

  • 00880304524255 ()

  • 58 mm Shell Size Liner Size G
010000666

  • Acetabular shell
No Description
Zimmer, Inc.
00-5916-070-09
In Commercial Distribution

  • 00889024000445 ()

  • Size G, (5.5 mm Under the Condyles)


  • Tibial insert
Surgical Instrument Guide pin used during OPRA™ Fixture removal. Provides a guiding system to centre the Trephine aligned to the Fixture when used together with Guide Sleeve.
Integrum AB
2617
In Commercial Distribution

  • 07340152102225 ()


  • Internal-external leg prosthesis osseointegration bar
The intended purpose of the Fixture Removal kit is, by an Integrum certified physician, to perform the removal of a Femur Fixture. Consist of instruments: Mounting Tool for Trephine Guide Pins Fixture Mount Screw Fixture Mount Hammer Hammer Handle Fixture Mount Connector Fixture Mount Connector Screw Fixture Mount Handle Spanner 8 mm Spanner 12 mm Spanner 14 mm Spanner 19 mm
Integrum AB
2532
In Commercial Distribution

  • 07340152102034 ()


  • Internal-external leg prosthesis osseointegration bar
The intended purpose is for certified surgeons, to conduct the surgical procedure for Abutment Extraction, facilitate removal of Abutment and Abutment Screw within an OPRA™ Implant System in a patient. Consist of instruments: Clamp head Clamp head Pusher Clamp head Screw Pressure Peg Hex T-Handle 5 mm Spanner 14 mm Spanner 12 mm Spanner 10 mm
Integrum AB
2531
In Commercial Distribution

  • 07340152101976 ()


  • Internal-external leg prosthesis osseointegration bar
Deflux metal needle
PALETTE LIFE SCIENCES, INC.
3.7 FR x 23 G (tip) x 350 mm
In Commercial Distribution

  • 00850004725023 ()

  • Length: 350 Millimeter
  • Needle Gauge: 23 Gauge
DX1201

  • Submucosal injection needle
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)
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