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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 Calf Implant - 00812790022946

Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 140 cc
Sientra, Inc.
402-260U
Not in Commercial Distribution

  • 00812790022946 ()

  • Volume: 140 cc
402-260U

  • Silicone-block tissue reconstructive material

SIENTRA Calf Implant - 00812790022922

Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 50 cc
Sientra, Inc.
402-160U
Not in Commercial Distribution

  • 00812790022922 ()

  • Volume: 50 cc
402-160U

  • Silicone-block tissue reconstructive material

SIENTRA Calf Implant - 00812790022915

Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 30 cc
Sientra, Inc.
402-100U
Not in Commercial Distribution

  • 00812790022915 ()

  • Volume: 30 cc
402-100U

  • Silicone-block tissue reconstructive material

SIENTRA Calf Implant - 00812790022908

Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 15 cc
Sientra, Inc.
402-065U
Not in Commercial Distribution

  • 00812790022908 ()

  • Volume: 15 cc
402-065U

  • Silicone-block tissue reconstructive material

SIENTRA Calf Implant - 00812790022892

Calf Implant, Silicone Elastomer, Asymmetrical, Smooth, 175 cc
Sientra, Inc.
412-230U
Not in Commercial Distribution

  • 00812790022892 ()

  • Volume: 175 cc
412-230U

  • Silicone-block tissue reconstructive material

SIENTRA Calf Implant - 00812790022885

Calf Implant, Silicone Elastomer, Asymmetrical, Smooth, 125 cc
Sientra, Inc.
412-200U
Not in Commercial Distribution

  • 00812790022885 ()

  • Volume: 125 cc
412-200U

  • Silicone-block tissue reconstructive material

SIENTRA Calf Implant - 00812790022878

Calf Implant, Silicone Elastomer, Asymmetrical, Smooth, 70 cc
Sientra, Inc.
412-150U
Not in Commercial Distribution

  • 00812790022878 ()

  • Volume: 70 cc
412-150U

  • Silicone-block tissue reconstructive material

Arthrex® - 00888867218208

IB Kit, PEEK, w/ CC FT and JumpStart
ARTHREX, INC.
AR-1788PJ-CP
In Commercial Distribution

  • 00888867218208 ()
AR-1788PJ-CP

  • Tendon/ligament bone anchor, non-bioabsorbable

Tranquil-C™ - B6785233760

Cervical IBD 12x18x14 Planar, 0 Deg, 0.88 cc
NEXUS SPINE, L.L.C.
523376
In Commercial Distribution

  • B6785233760 ()

  • Width: 18 Millimeter
  • Length: 14 Millimeter
  • Height: 12 Millimeter


  • Metallic spinal interbody fusion cage

Tranquil-C™ - B6785233750

Cervical IBD 11x18x14 Planar, 0 Deg, 0.81 cc
NEXUS SPINE, L.L.C.
523375
In Commercial Distribution

  • B6785233750 ()

  • Width: 18 Millimeter
  • Length: 14 Millimeter
  • Height: 11 Millimeter


  • Metallic spinal interbody fusion cage
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