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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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Arthrex® - 00888867389557

MIS 3.9MM BC ACHILLES SPDBRG W/ FT CC
ARTHREX, INC.
AR-9928BH-MIS
In Commercial Distribution

  • 00888867389557 ()
AR-9928BH-MIS

  • Tendon/ligament bone anchor, bioabsorbable

Arthrex® - 00888867389540

MIS 3.9MM BC ACHILLES SPDBRG W/ DX CC
ARTHREX, INC.
AR-9928BC-MIS
In Commercial Distribution

  • 00888867389540 ()
AR-9928BC-MIS

  • Tendon/ligament bone anchor, bioabsorbable

Arthrex® - 00888867389496

BC ACHILLES SPDBRG W/ FT CC, 3.9 MM
ARTHREX, INC.
AR-9928BC-CP
In Commercial Distribution

  • 00888867389496 ()
AR-9928BC-CP

  • Tendon/ligament bone anchor, bioabsorbable

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

Comfortox - 00817169021957

.5 CC 31 Gauge X 8 MM 100
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
.5 CC 31 Gauge X 8 MM 100
In Commercial Distribution

  • 00817169021957 ()


  • Insulin syringe/needle, basic

Comfortox - 00817169021940

.3 CC 31 Gauge X 8 MM 100
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
.3 CC 31 Gauge X 8 MM 100
In Commercial Distribution

  • 00817169021940 ()
  • 10817169021947 ()


  • Insulin syringe/needle, basic

SIENTRA Pectoral Implant - 00812790023165

Pectoral Implant, Silicone Elastomer, Textured, Left, 190 cc
Sientra, Inc.
20132-150EU
Not in Commercial Distribution

  • 00812790023165 ()

  • Volume: 190 cc
20132-150EU

  • Pectoral implant

SIENTRA Pectoral Implant - 00812790023141

Pectoral Implant, Silicone Elastomer, Textured, Right, 230 cc
Sientra, Inc.
20132-160DU
Not in Commercial Distribution

  • 00812790023141 ()

  • Volume: 230 cc
20132-160DU

  • Pectoral implant

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 - 00812790022939

Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 70 cc
Sientra, Inc.
402-190U
Not in Commercial Distribution

  • 00812790022939 ()

  • Volume: 70 cc
402-190U

  • Silicone-block tissue reconstructive material
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