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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No Description
BIOTECHNOLOGY INSTITUTE SL
IIPSCA6010
In Commercial Distribution

  • 08435389821243 ()


  • Screw endosteal dental implant, two-piece
No Description
EITAN MEDICAL LTD
12000-000-0044
In Commercial Distribution

  • 27290109153081 ()
  • 17290109153084 ()
12000-000-0044

  • Electric infusion pump administration set, single-use
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Beckman Coulter, Inc.
387620
In Commercial Distribution

  • 15099590231859 ()
387620

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE
Not in Commercial Distribution

  • 10888234500285 ()
THROMBOTYPE

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
Box of 200 Sterile Single-Use Lancing Device 30Gauge
ASAHI POLYSLIDER COMPANY,LIMITED
024-206
In Commercial Distribution

  • 20812608030228 ()
  • 00812608030224 ()
  • 00812608030248 ()

  • Needle Gauge: 30 Gauge
OTD Safety 30g US/CA/LATAM 200

  • Manual blood lancing device, single-use
RAPIDPoint® 400 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 400 analyzer.
Siemens Healthcare Diagnostics Inc.
10844810
In Commercial Distribution

  • 00630414947525 ()
10844810

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4, #4 resorbable captures/ca[ture holster, 2 #2 USP UHMWPE braided sutures, two thermoplastic tip covers per kit- 6 kits per shipper ( 10858816006061
ZIPTEK LLC
Rb41-S-4
In Commercial Distribution

  • 10858816006061 ()
61

  • Tendon/ligament bone anchor, bioabsorbable
The Access GI Monitor Calibrators are intended to calibrate the Access GI Monitor assay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
387688
In Commercial Distribution

  • 15099590231835 ()
387688

  • Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)
The Access OV Monitor Calibrators are intended to calibrate the Access OV Monitor assay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
386358
In Commercial Distribution

  • 15099590232375 ()
386358

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
The Access BR Monitor Calibrators are intended to calibrate the Access BR Monitor assay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
387647
In Commercial Distribution

  • 15099590231866 ()
387647

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
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