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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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TR Optics - 00781096319015

Spectacle Frame, Size 51-18-145
MCGEE GROUP, INC., THE
TO Memphis Gold
In Commercial Distribution

  • 00781096319015 ()
TRMEMPHIS0GOLD0OPT

  • Spectacle frame

TR Optics - 00781096319008

Spectacle Frame, Size 50-19-140
MCGEE GROUP, INC., THE
TO Houston Tortoise
In Commercial Distribution

  • 00781096319008 ()
TRHOUSTON0TORT0OPT

  • Spectacle frame

TR Optics - 00781096318995

Spectacle Frame, Size 50-19-52
MCGEE GROUP, INC., THE
TO Houston Black
In Commercial Distribution

  • 00781096318995 ()
TRHOUSTON0BLCK0OPT

  • Spectacle frame

TR Optics - 00781096318988

Spectacle Frame, Size 49-20-145
MCGEE GROUP, INC., THE
TO Dayton Tortoise
In Commercial Distribution

  • 00781096318988 ()
TRDAYTON0TORT0OPT

  • Spectacle frame

TR Optics - 00781096318971

Spectacle Frame, Size 49-20-145
MCGEE GROUP, INC., THE
TO Dayton Gold
In Commercial Distribution

  • 00781096318971 ()
TRDAYTON0GOLD0OPT

  • Spectacle frame

INFINITY™ Occipitocervical Upper Thoracic System - 00643169549647

DOMINO G3603635 OFFSET O/O 3.5/5.5/6.35
MEDTRONIC SOFAMOR DANEK, INC.
G3603635
In Commercial Distribution

  • 00643169549647 ()

  • 3.2/3.5mm to 5.5/6.0/6.35mm


  • Bone-screw internal spinal fixation system connector

INFINITY™ Occipitocervical Upper Thoracic System - 00643169527843

DOMINO 3603635 OFFSET O/O 5.5/6.0/6.35mm
MEDTRONIC SOFAMOR DANEK, INC.
3603635
In Commercial Distribution

  • 00643169527843 ()

  • 3.2/3.5mm to 5.5/6.0/6.35mm


  • Spinal bone screw, non-bioabsorbable

Cardiva VASCADE MVP VVCS 6-12F - M729800612C0

The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-612C
In Commercial Distribution

  • M729800612C2 ()
  • M729800612C0 ()
  • M729800612C1 ()
  • M729800612C3 ()

  • Catheter Gauge: 6 to 12 French


  • Femoral artery closure plug/patch, collagen

Cardiva VASCADE MVP XL VVCS 10-12F - M7298001012XL0

The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-1012XL
In Commercial Distribution

  • M7298001012XL2 ()
  • M7298001012XL0 ()
  • M7298001012XL1 ()
  • M7298001012XL3 ()

  • Catheter Gauge: 10 to 12 French


  • Femoral artery closure plug/patch, collagen

Lineum® OCT - 00880304986367

No Description
BIOMET SPINE LLC
14-525111E
In Commercial Distribution

  • 00880304986367 ()

  • Small Nut Head to Head Cross-Connector
14-525111E

  • Bone-screw internal spinal fixation system, sterile
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