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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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LINEUM OCT SPINE SYSTEM - 00888480488149

No Description
BIOMET SPINE LLC
14-524207
In Commercial Distribution

  • 00888480488149 ()

  • LINEUM 3.5MM X 7MM CC SCREW
14-524207

  • Bone-screw internal spinal fixation system, non-sterile

LINEUM OCT SPINE SYSTEM - 00888480488132

No Description
BIOMET SPINE LLC
14-524206
In Commercial Distribution

  • 00888480488132 ()

  • LINEUM 3.5MM X 6MM CC SCREW
14-524206

  • Bone-screw internal spinal fixation system, non-sterile

LINEUM OCT SPINE SYSTEM - 00888480488125

No Description
BIOMET SPINE LLC
14-524205
In Commercial Distribution

  • 00888480488125 ()

  • LINEUM 3.5MM X 5MM CC SCREW
14-524205

  • Bone-screw internal spinal fixation system, non-sterile

AoN Implants - 00840192704474

Manual - Ratchet - Fix Key for Prosthetic D.1.20 mm. Extra Long L.25 mm. - CC- IH - EH
FAICO MEDICAL LLC
AST12030APCRB
Not in Commercial Distribution

  • 00840192704474 ()


  • Dental implant system

Mini-Bowls - D701BMM22

Non-stick silicone for acrylics, with suction base. Medium, 30 cc (Set of 2) (1 5/8” diameter)
PULPDENT CORPORATION
B-MM2
In Commercial Distribution

  • D701BMM22 ()
  • D701BMM1 ()


  • Dental material mixing surface, chairside, reusable

SciPharm NewCore, Core Build-Up Restorative Automix - D801SP57013T1

NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. Blue Shade. Trial Size.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 57-013 T
In Commercial Distribution

  • D801SP57013T1 ()
57-013

  • Dental composite resin

Duraliner II – Nylon Fiber - D9471601N1

Denture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 8.5 cc Liquid (113 GR POWDER / 118 ML LIQUID)
Reliance Dental Manufacturing Co Inc
1601-N
In Commercial Distribution

  • D9471601N1 ()


  • Dental impression tray material

Duraliner II - Clear - D9471601C1

Denture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 8.5 cc Liquid (113 GR POWDER / 118 ML LIQUID)
Reliance Dental Manufacturing Co Inc
1601-C
In Commercial Distribution

  • D9471601C1 ()


  • Dental impression tray material

Duraliner II - Pink - D9471601

Denture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 8.5 cc Liquid (113 GR POWDER / 118 ML LIQUID)
Reliance Dental Manufacturing Co Inc
1601
In Commercial Distribution

  • D9471601 ()


  • Dental impression tray material

Durabase Soft - Clear - D9471506C1

Denture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 8.5 cc Liquid (113 GR POWDER / 118 ML LIQUID)
Reliance Dental Manufacturing Co Inc
1506-C
In Commercial Distribution

  • D9471506C1 ()


  • Dental impression tray material
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