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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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KneeAlign 2 - 00851977007246

Narrow Distal Guide
Orthalign, Inc.
402441
In Commercial Distribution

  • 00851977007246 ()
402441

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007239

KneeAlign 2 Instrument Kit
Orthalign, Inc.
402064-10
In Commercial Distribution

  • 00851977007239 ()
402064-10

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Evolution 2 - 00850033615005

Evolution, DVT, EV0001, Qty 1
THERMOTEK, INC.
0V12X1009M01
In Commercial Distribution

  • 00850033615005 ()
0V12X1009M01

  • Single-chamber venous compression system garment, single-use

IDB 2 - 00850039704055

Indicated for the fabrication, by additive manufacturing, of Indirect Bonding Tray
Sprintray, Inc.
SRI-0202012
In Commercial Distribution

  • 10850039704052 ()
  • 00850039704055 ()

  • Total Volume: 1 Liter
SRI-0202012

  • Dental appliance fabrication material, resin

Try-In 2 - 00850039704154

Intended to be used to fabricate teeth models, which can be used for fabricating Try-In Dentures for cosmetic and not masticatory purposes.
Sprintray, Inc.
SRI-0202031
In Commercial Distribution

  • 10850039704151 ()
  • 00850039704154 ()

  • Total Volume: 1 Liter
SRI-0202031

  • Dental appliance fabrication material, resin

Preference 2 - M555284550040

ø4.5 Triple Lead Screw Assembly, 40mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4550-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284550030

ø4.5 Triple Lead Screw Assembly, 30mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4550-030

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284509045

5.5 HF Monoaxial Tapered, triple Lead Screw - ø4.5mm, 45mm
AMEDICA CORPORATION
F
Not in Commercial Distribution

  • M555284509045 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 45 Millimeter
28-4509-045

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284509040

5.5 HF Monoaxial Tapered, triple Lead Screw - ø4.5mm, 40mm
AMEDICA CORPORATION
F
Not in Commercial Distribution

  • M555284509040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4509-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284509035

5.5 HF Monoaxial Tapered, triple Lead Screw - ø4.5mm, 35mm
AMEDICA CORPORATION
F
Not in Commercial Distribution

  • M555284509035 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 35 Millimeter
28-4509-035

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284509030

5.5 HF Monoaxial Tapered, triple Lead Screw - ø4.5mm, 30mm
AMEDICA CORPORATION
F
Not in Commercial Distribution

  • M555284509030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4509-030

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284509025

5.5 HF Monoaxial Tapered, triple Lead Screw - ø4.5mm, 25mm
AMEDICA CORPORATION
F
Not in Commercial Distribution

  • M555284509025 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 25 Millimeter
28-4509-025

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284501045

ø4.5 x 45mm Reduction Polyaxial Screw Assembly
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555284501045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4501-045

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284501040

ø4.5 x 40mm Reduction Polyaxial Screw Assembly
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555284501040 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 40 Millimeter
28-4501-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284501035

ø4.5 x 35mm Reduction Polyaxial Screw Assembly
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555284501035 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4501-035

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284501030

ø4.5 x 30mm Reduction Polyaxial Screw Assembly
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555284501030 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 30 Millimeter
28-4501-030

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284501025

ø4.5 x 25mm Reduction Polyaxial Screw Assembly
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555284501025 ()

  • Length: 25 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4501-025

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284500045

ø4.5 x 45mm Polyaxial Screw Assembly
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555284500045 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 45 Millimeter
28-4500-045

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284500040

ø4.5 x 40mm Polyaxial Screw Assembly
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555284500040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4500-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284500035

ø4.5 x 35mm Polyaxial Screw Assembly
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555284500035 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 35 Millimeter
28-4500-035

  • Spinal bone screw, non-bioabsorbable
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