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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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OsteoXcell BA - 05060548020231

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 3 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box
BIOSTONE CO. LIMITED
OSBA-003
In Commercial Distribution

  • 05060548020231 ()
OSBA-003

  • Bone matrix implant, synthetic, non-antimicrobial

MESACUP BP230 ELISA Kit - 04987506015966

The MESACUP BP230 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELISA) for the detection of anti BP 230 antibodies in human serum. The MESACUP BP230 ELISA Kit is intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphgoid in conjunction with otehr laboratory and clinical findings.
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
48 wells
In Commercial Distribution

  • 04987506015966 ()
7613US

  • Bullous pemphigoid antigen 1 (BPAG1) antibody IVD, kit, enzyme immunoassay (EIA)

MESACUP BP180 ELISA Kit - 04987506015959

The MESACUP BP180 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELISA) for the detection of anti BP 180 antibodies in human serum. The MESACUP BP180 ELISA Kit is intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphgoid in conjunction with otehr laboratory and clinical findings.
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
48 wells
In Commercial Distribution

  • 04987506015959 ()
7695US

  • Bullous pemphigoid antigen 2 (BPAG2) antibody IVD, kit, enzyme immunoassay (EIA)

Surgical Direct - B382SD865300

6.5mm 30° HD Laparoscope, 35cm Working Length, Autoclavable, Made in Germany
Surgical Direct, Inc.
SD865-30
In Commercial Distribution

  • B382SD865300 ()
SD865-30

  • Fibreoptic light cable

Surgical Direct - B382SD865000

6.5mm 0° HD Laparoscope, 35cm Working Length, Autoclavable, Made in Germany
Surgical Direct, Inc.
SD865-00
In Commercial Distribution

  • B382SD865000 ()
SD865-00

  • Rigid video laparoscope

Integrity Implant Fixation Kit - M06760001020

Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy.
Anika Therapeutics, Inc.
6000102
In Commercial Distribution

  • M06760001020 ()


  • Soft-tissue/mesh anchor, bioabsorbable
  • Tendon/ligament bone anchor, non-bioabsorbable

NA - 20845854061609

Smoke Evacuation Tubing (Non-Sterile) 1.4 in (6.4mm) x 2 ft (.6m)
Conmed Corporation
ST10105
In Commercial Distribution

  • 30845854061606 ()
  • 20845854061609 ()
  • 00845854061605 ()
  • 10851136002911 ()
ST10105

  • Surgical plume evacuation system tube

Admira Flow - E22124941

Highly Biocompatible flowable Ormocer Composite in unit dose caps or syringes.
VOCO GmbH
2494
In Commercial Distribution

  • E22124941 ()
  • E22124940 ()
2494

  • Dental composite resin

Admira Flow - E22124931

Highly Biocompatible flowable Ormocer Composite in unit dose caps or syringes.
VOCO GmbH
2493
In Commercial Distribution

  • E22124931 ()
  • E22124930 ()
2493

  • Dental composite resin

Admira Flow - E22124921

Highly Biocompatible flowable Ormocer Composite in unit dose caps or syringes.
VOCO GmbH
2492
In Commercial Distribution

  • E22124921 ()
  • E22124920 ()
2492

  • Dental composite resin
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