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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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STAT PROFILE pHOx CO-OXIMETER TUBING ASSEMBLY PUMP HARNESS
NOVA BIOMEDICAL CORPORATION
PHOX
In Commercial Distribution

  • 00385480279499 ()
27949

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
STAT PROFILE pHOx CO-OXIMETER FLUSH FIXTURE
NOVA BIOMEDICAL CORPORATION
pHOx Co-ox
In Commercial Distribution

  • 00385480268653 ()
26865

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
STAT PROFILE pHOx CO-OXIMETER REAGENT CARTRIDGE
NOVA BIOMEDICAL CORPORATION
PHOX
In Commercial Distribution

  • 00385480250559 ()
25055

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA CO-OXIMETER DEPROTEINIZING SOLUTION
NOVA BIOMEDICAL CORPORATION
1
In Commercial Distribution

  • 00385480180986 ()
18098

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
36 test
In Commercial Distribution

  • 08887581000016 ()
07110888036

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
18 test
In Commercial Distribution

  • 08887581000009 ()
0711088018

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
An instrument that eliminates unwanted glare from surfaces that are being examined.
Globalmed Holdings, LLC
GMD55100010
In Commercial Distribution

  • 00850033167122 ()
GMD55100010

  • Multi-purpose digital medical camera lens, otoscopic
No Description
DIAGNOSTICA STAGO
00944
In Commercial Distribution

  • 03607450009446 ()


  • Protein C IVD, kit, enzyme immunoassay (EIA)
Round LED back light used for Graft Boards in processing
Cole Instruments Inc
Graft Board Round LED Backlight
In Commercial Distribution

  • 00810072350947 ()
614.000

  • Fibreoptic operating light system
No Description
MERIT MEDICAL SYSTEMS, INC.
00884450433898
In Commercial Distribution

  • 10884450433895 ()
  • 00884450433898 ()

  • Sheath Size-8.3 cm tapered to 3.2 cm x 264 cm
SH-01/C

  • Electromagnetic surgical navigation device tracking system
joimax® Endoscopic Trolley 4th Gen.
Joimax GmbH
JEST2020
Not in Commercial Distribution

  • 04056634003517 ()

  • up to 6 devices and 3 monitors, drawer, infusion s
JEST2020

  • Medical device integration rack
ALT LNR TRL 10° FC G8 36
Exactech, Inc.
01-031-48-0836
In Commercial Distribution

  • 10885862555571 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0836

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G8 32
Exactech, Inc.
01-031-48-0832
In Commercial Distribution

  • 10885862555564 ()

  • Angle: 10 degree
  • Lumen/Inner Diameter: 32 Millimeter
  • Lateral angle of the face with respect to base plane
01-031-48-0832

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G7 40
Exactech, Inc.
01-031-48-0740
In Commercial Distribution

  • 10885862555533 ()

  • Angle: 10 degree
  • Lumen/Inner Diameter: 40 Millimeter
  • Lateral angle of the face with respect to base plane
01-031-48-0740

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G7 36
Exactech, Inc.
01-031-48-0736
In Commercial Distribution

  • 10885862555526 ()

  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
  • Lumen/Inner Diameter: 36 Millimeter
01-031-48-0736

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G7 32
Exactech, Inc.
01-031-48-0732
In Commercial Distribution

  • 10885862555519 ()

  • Angle: 10 degree
  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 32 Millimeter
01-031-48-0732

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G6 40
Exactech, Inc.
01-031-48-0640
In Commercial Distribution

  • 10885862555489 ()

  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
  • Lumen/Inner Diameter: 40 Millimeter
01-031-48-0640

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G6 36
Exactech, Inc.
01-031-48-0636
In Commercial Distribution

  • 10885862555472 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Angle: 10 degree
  • Lateral angle of the face with respect to base plane
01-031-48-0636

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G6 32
Exactech, Inc.
01-031-48-0632
In Commercial Distribution

  • 10885862555465 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0632

  • Acetabulum prosthesis trial, prefabricated, reusable
ALT LNR TRL 10° FC G5 36
Exactech, Inc.
01-031-48-0536
In Commercial Distribution

  • 10885862555427 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0536

  • Acetabulum prosthesis trial, prefabricated, reusable
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