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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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SIENTRA Gluteal Implant - 00812790022984

Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 300 cc
Sientra, Inc.
20922-160U
Not in Commercial Distribution

  • 00812790022984 ()

  • Volume: 300 cc
20922-160U

  • Silicone-block tissue reconstructive material

SIENTRA Gluteal Implant - 00812790022977

Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 260 cc
Sientra, Inc.
20922-155U
Not in Commercial Distribution

  • 00812790022977 ()

  • Volume: 260 cc
20922-155U

  • Silicone-block tissue reconstructive material

SIENTRA Gluteal Implant - 00812790022960

Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 225 cc
Sientra, Inc.
20922-150U
Not in Commercial Distribution

  • 00812790022960 ()

  • Volume: 225 cc
20922-150U

  • Silicone-block tissue reconstructive material

TRIPLE LINE SET WITH SAFEDRAW(TM) - 00886333679133

A 3-way 20 drops,60" tubing length each AdSet connected with 3x 3cc transducers at each end. 1 channel is connected with a septum with a 5cc syringe with touchguard stops at 2cc via a 48" & 6" Pressure Tubing & a 12" pressure Tubing from Patient. The other 2 lines connects directly to the 3cc transducer each, a 3-way stopcock and a 6" Pressure Tubing. The 3rd line has an additional 3-Way stopcock to the 6" Pressure Tubing. It includes a separately packed 4xmale & 4xfemale protective caps.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
687913
In Commercial Distribution

  • 50886333679138 ()
  • 00886333679133 ()

  • 3 cc transducers
687913

  • Arterial blood sampling kit

DTX(TM) PLUS DT-NN - 00886333620197

Single 30 cc transducer includes a separately packed 2x male protective caps.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682019
In Commercial Distribution

  • 50886333620192 ()
  • 00886333620197 ()

  • 30 cc transducer
682019

  • Invasive-pressure external transducer, single-use

Newport Biologics Bone Graft Putty Mineral Collagen Composite - D74570BIOBGP200

Bone Graft Putty Mineral Collagen Composite
Prismatik Dentalcraft, Inc
70-BIO-BGP20
In Commercial Distribution

  • D74570BIOBGP200 ()

  • Volume, 2.0 cc
70-BIO-BGP20

  • Dental bone matrix implant, synthetic

Newport Biologics Bone Graft Putty Mineral Collagen Composite - D74570BIOBGP100

Bone Graft Putty Mineral Collagen Composite
Prismatik Dentalcraft, Inc
70-BIO-BGP10
In Commercial Distribution

  • D74570BIOBGP100 ()

  • Volume, 1.0 cc
70-BIO-BGP10

  • Dental bone matrix implant, synthetic

Newport Biologics Bone Graft Putty Mineral Collagen Composite - D74570BIOBGP050

Bone Graft Putty Mineral Collagen Composite
Prismatik Dentalcraft, Inc
70-BIO-BGP05
In Commercial Distribution

  • D74570BIOBGP050 ()

  • Volume, 0.5 cc
70-BIO-BGP05

  • Dental bone matrix implant, synthetic

PROGENIX™ PUTTY and PROGENIX™ PLUS - 00763000140571

DBM 006010 PROGENIX PLUS PUTTY 10CC
MEDTRONIC SOFAMOR DANEK, INC.
006010
Not in Commercial Distribution

  • 00763000140571 ()

  • 10 CC volume


  • Bone matrix implant, human-derived

PROGENIX™ PUTTY and PROGENIX™ PLUS - 00763000140564

DBM 006005 PROGENIX PLUS PUTTY 5CC
MEDTRONIC SOFAMOR DANEK, INC.
006005
Not in Commercial Distribution

  • 00763000140564 ()

  • 5 CC volume


  • Bone matrix implant, human-derived
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