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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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OSTEO-Derm Enhanced - 00850011613146

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE15x20
In Commercial Distribution

  • 00850011613146 ()

  • 15mm x 20mm


  • Collagen dental regeneration membrane

OSTEO-Derm - 00850011613054

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD30x40
In Commercial Distribution

  • 00850011613054 ()

  • 30mm x 40mm


  • Collagen dental regeneration membrane

OSTEO-Derm - 00850011613047

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD20x30
In Commercial Distribution

  • 00850011613047 ()

  • 20mm x 30mm


  • Collagen dental regeneration membrane

OSTEO-Derm - 00850011613030

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD15x20
In Commercial Distribution

  • 00850011613030 ()

  • 15mm x 20mm


  • Collagen dental regeneration membrane

OSTEO-Flex - 00850011613023

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOF30x40
In Commercial Distribution

  • 00850011613023 ()

  • 30mm x 40mm


  • Collagen dental regeneration membrane

OSTEO-Flex - 00850011613016

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOF20x30
In Commercial Distribution

  • 00850011613016 ()

  • 20mm x 30mm


  • Collagen dental regeneration membrane

OSTEO-Flex - 00850011613009

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOF15x20
In Commercial Distribution

  • 00850011613009 ()

  • 15mm x 20mm


  • Collagen dental regeneration membrane

BioBrush - 00850011453285

BioBrush Powered Debridement Device (Large Brush)
OSTEOREMEDIES, LLC
DDBK02
In Commercial Distribution

  • 00850011453285 ()
DDBK02

  • Arthroscopic shaver/electrosurgical system

Remedy Spacer - 00850011453278

REMEDY® Stemmed Knee - Adjunct Base
OSTEOREMEDIES, LLC
RSKABASE
In Commercial Distribution

  • 00850011453278 ()
RSKABASE

  • Instrument tray, reusable

Remedy Spacer - 00850011453261

REMEDY® Stem Extension Trial 230, 13/11 OD
OSTEOREMEDIES, LLC
RTS230
In Commercial Distribution

  • 00850011453261 ()
RTS230

  • Knee tibia prosthesis trial, reusable

Remedy Spacer - 00850011453254

REMEDY® Stem Extension Trial 150, 13/11 OD
OSTEOREMEDIES, LLC
RTS150
In Commercial Distribution

  • 00850011453254 ()
RTS150

  • Knee tibia prosthesis trial, reusable

Remedy Spacer - 00850011453247

REMEDY® Stem Extension Component 230, 13/11 OD
OSTEOREMEDIES, LLC
RSK230
In Commercial Distribution

  • 00850011453247 ()
RSK230

  • Orthopaedic cement spacer

Remedy Spacer - 00850011453230

REMEDY® Stem Extension Component 150, 13/11 OD
OSTEOREMEDIES, LLC
RSK150
In Commercial Distribution

  • 00850011453230 ()
RSK150

  • Orthopaedic cement spacer

Remedy Spacer - 00850011453216

Remedy Stemmed Knee Spacer Case
OSTEOREMEDIES, LLC
RSKBASE
In Commercial Distribution

  • 00850011453216 ()
RSKBASE

  • Instrument tray, reusable

Remedy Spacer - 00850011453209

Remedy Shoulder Base Assembly
OSTEOREMEDIES, LLC
RSBASE
In Commercial Distribution

  • 00850011453209 ()
RSBASE

  • Instrument tray, reusable

Remedy Spacer - 00850011453193

Remedy Knee Base Assembly
OSTEOREMEDIES, LLC
RKBASE
In Commercial Distribution

  • 00850011453193 ()
RKBASE

  • Instrument tray, reusable

Remedy Spacer - 00850011453186

Remedy Hip Spacer Base Assembly
OSTEOREMEDIES, LLC
RHBASE
In Commercial Distribution

  • 00850011453186 ()
RHBASE

  • Instrument tray, reusable

Remedy Spacer - 00850011453179

Remedy Spacer System Short Lid
OSTEOREMEDIES, LLC
REMLIDSH
In Commercial Distribution

  • 00850011453179 ()
REMLIDSH

  • Instrument tray, reusable

Remedy Spacer - 00850011453162

Remedy Spacer System Lid
OSTEOREMEDIES, LLC
REMLID
In Commercial Distribution

  • 00850011453162 ()
REMLID

  • Instrument tray, reusable

Remedy Spacer - 00850011453100

REMEDY® Radel Head Trial 40mm
OSTEOREMEDIES, LLC
RRTHDXS
In Commercial Distribution

  • 00850011453100 ()
RRTHDXS

  • Femoral head prosthesis trial

Remedy Spacer - 00850011453094

REMEDY® Acetabular Cup 40mm ID/48mm OD Trial
OSTEOREMEDIES, LLC
RHACTXS
In Commercial Distribution

  • 00850011453094 ()
RHACTXS

  • Acetabulum prosthesis trial, prefabricated, reusable

Remedy Spacer - 00850011453087

REMEDY® Acetabular Cup 40mm ID/48mm OD
OSTEOREMEDIES, LLC
RHACXS
In Commercial Distribution

  • 00850011453087 ()
RHACXS

  • Orthopaedic cement spacer

Remedy Spacer - 00850011453070

REMEDY® Modular Head 40mm
OSTEOREMEDIES, LLC
RHHDXS
In Commercial Distribution

  • 00850011453070 ()
RHHDXS

  • Orthopaedic cement spacer

Remedy Spectrum GV Spacer - 00850011453063

REMEDY SPECTRUM® GV Femoral Head - 40mm
OSTEOREMEDIES, LLC
GVHDXS
In Commercial Distribution

  • 00850011453063 ()
GVHDXS

  • Orthopaedic cement spacer

L-Varlock - 00850011324141

Instrument, Inserter
SPINESOURCE INC
141
In Commercial Distribution

  • 00850011324141 ()
HD0064

  • Orthopaedic inorganic implant inserter/extractor, reusable

L-Varlock - 00850011324127

Instrument, Implant Stabilizer
SPINESOURCE INC
127
In Commercial Distribution

  • 00850011324127 ()
SP-002

  • Orthopaedic implantation sleeve, reusable

L-Varlock - 00850011324110

The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
110
In Commercial Distribution

  • 00850011324110 ()

  • Height: 9 Millimeter
  • Width: 10 Millimeter
VAL-CA-10-09

  • Metallic spinal fusion cage, non-sterile

L-Varlock - 00850011324097

Instrument, Expansion Screwdriver, Long
SPINESOURCE INC
097
In Commercial Distribution

  • 00850011324097 ()
SD-4100

  • Surgical screwdriver, reusable

L-Varlock - 00850011324080

Instrument, Disc Shaver, 13mm
SPINESOURCE INC
080
In Commercial Distribution

  • 00850011324080 ()
DS-113

  • Bone-resection orthopaedic reamer, reusable

L-Varlock - 00850011324073

Instrument, Disc Shaver, 12mm
SPINESOURCE INC
073
In Commercial Distribution

  • 00850011324073 ()
DS-112

  • Bone-resection orthopaedic reamer, reusable
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