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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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RelayPro Thoracic Stent-Graft System - 00843576168688

Endovascular Stent-Graft System
Bolton Medical Inc.
28-N4-32-250-30U
In Commercial Distribution

  • 00843576168688 ()

  • Outer Diameter: 32 Millimeter
  • Outer Diameter: 30 Millimeter
  • Length: 250 Millimeter
  • Catheter Gauge: 21 French
28-N4-32-250-30U

  • Descending thoracic aorta endovascular stent-graft

SULFLUX - 04537693900639

Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KP-05
In Commercial Distribution

  • 14537693900636 ()
  • 04537693900639 ()


  • Apheresis system filter, whole blood

Plasmaflo - 04537693005365

The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinical setting.
ASAHIKASEI MEDICAL MT K.K.
OP-05W(A)
In Commercial Distribution

  • 04537693005365 ()
  • 24537693005369 ()
  • 14537693005362 ()


  • Apheresis system filter, whole blood

Durolane - 04260648380094

No Description
Arcera GmbH
N/A
In Commercial Distribution

  • 04260648380094 ()


  • Synovial fluid supplementation medium

Supartz - 04260648380056

No Description
Arcera GmbH
n/a
In Commercial Distribution

  • 04260648380056 ()
  • 04260648380070 ()


  • Synovial fluid supplementation medium

Synvisc One - 04260648380049

No Description
Arcera GmbH
N/A
In Commercial Distribution

  • 04260648380049 ()


  • Synovial fluid supplementation medium

Synvisc - 04260648380032

No Description
Arcera GmbH
N/A
In Commercial Distribution

  • 04260648380032 ()
  • 04260648380087 ()


  • Synovial fluid supplementation medium

Euflexxa - 04260648380025

No Description
Arcera GmbH
N/A
In Commercial Distribution

  • 04260648380025 ()
  • 04260648380063 ()


  • Synovial fluid supplementation medium

Monovisc - 04260648380018

No Description
Arcera GmbH
N/A
In Commercial Distribution

  • 04260648380018 ()


  • Synovial fluid supplementation medium

Orthovisc - 04260648380001

No Description
Arcera GmbH
N/A
In Commercial Distribution

  • 04260648380001 ()


  • Synovial fluid supplementation medium
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