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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Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000310036
In Commercial Distribution

  • 00810000310036 ()


  • Adhesive bandage
Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 00850391007306 3 Montage Flowable Static Mix Tips 00850391007313
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution

  • 00850391007320 ()


  • Synthetic bone graft
  • Bone matrix implant, synthetic, non-antimicrobial
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.694.396
In Commercial Distribution

  • 04038917926713 ()
  • 04038917926690 ()
72.694.396

  • Assay container IVD, single-use
Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 10.0 mL bottle for approximately 1000 tests
Supertechs, Inc.
6100D
In Commercial Distribution

  • B7826100D03 ()
6100D

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 0.5 mL vial for approximately 50 tests
Supertechs, Inc.
6100A
In Commercial Distribution

  • B7826100A00 ()
6100

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Flowable Dispenser 00850391007306
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution

  • 00850391007313 ()


  • Orthopaedic cement dispenser
TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons. IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days).
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
In Commercial Distribution

  • 00860003478707 ()
000-0219

  • Multi-parameter urinary monitoring system catheter set
Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000319954
In Commercial Distribution

  • 00810000319954 ()


  • Adhesive bandage
Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000310081
In Commercial Distribution

  • 00810000310081 ()


  • Adhesive bandage
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA200
In Commercial Distribution

  • 05430001477115 ()

  • Weight: 2.0 Gram


  • Dental bone matrix implant, animal-derived
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