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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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Dymaxeon - 00815500023448

Cap starter
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500023448 ()
77.1897

  • Surgical screwdriver, reusable

Dymaxeon - 00815500023424

Sounder - malleable
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500023424 ()
09.0653

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Dymaxeon - 00815500023417

Probe - Curved - Palm Handle
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023417 ()
09.0652

  • Surgical instrument handle, non-torque-limiting

Dymaxeon - 00815500023325

SINGLE-PACKED DYMAXEON PEDICLE SCREW - CANNULATED - CAP INCLUDED Ø4.5 X 30MM
BACK 2 BASIC DIRECT, LLC
5.5
In Commercial Distribution

  • 00815500023325 ()
06.6541B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500023318

SINGLE-PACKED DYMAXEON PEDICLE SCREW - CANNULATED - CAP INCLUDED Ø4.5 X 25MM
BACK 2 BASIC DIRECT, LLC
5.5
In Commercial Distribution

  • 00815500023318 ()
06.6540B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500023301

SINGLE-PACKED DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø4.5 X 30MM
BACK 2 BASIC DIRECT, LLC
5.5
In Commercial Distribution

  • 00815500023301 ()
06.6341B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500023295

SINGLE-PACKED DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø4.5 X 25MM
BACK 2 BASIC DIRECT, LLC
5.5
In Commercial Distribution

  • 00815500023295 ()
06.6340B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500023691

SINGLE-PACKED DYMAXEON PEDICLE SCREW CAP
BACK 2 BASIC DIRECT, LLC
5.5
In Commercial Distribution

  • 00815500023691 ()
46.0725-04

  • Bone-screw internal spinal fixation system, sterile

MANI CARBIDE BURS - 04546951534370

MANI CARBIDE BURS
MANI, INC.
2
In Commercial Distribution

  • 74546951534379 ()
  • 04546951534370 ()


  • Carbide dental bur, reusable

MetaStep™ Calcaneus Locking Plate - 04048266131775

TiAl6V4 ELI non-sterile
Merete GmbH
2
In Commercial Distribution

  • 04048266131775 ()

  • step: 2 mm
FH14002

  • Orthopaedic fixation plate, non-bioabsorbable
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