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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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Omni-Tract® - 10381780538134

Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 5in (3.8cm x 12.7cm)
INTEGRA LIFESCIENCES CORPORATION
3375R
In Commercial Distribution


  • 5.0" Length x 1.323" Width x 1.50" Height
3375R

  • Surgical retraction system, reusable

Omni-Tract® - 10381780538127

Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 4in (3.8cm x 10.2cm)
INTEGRA LIFESCIENCES CORPORATION
3374R
In Commercial Distribution


  • 4.0" Length x 1.323" Width x 1.50" Height
3374R

  • Surgical retraction system, reusable

Budde® - 10381780538097

Budde® Halo Retractor Side Rail Support
INTEGRA LIFESCIENCES CORPORATION
A1067
In Commercial Distribution


  • 16.4" Length x 16.2" Width x 5.7" Height
A1067

  • Medical table clamp

Cadence® - 10381780417132

45° Tibial Impactor Tip
Ascension Orthopedics, Inc.
10203102
In Commercial Distribution


  • 2.00in Lx 1.070in diameter
10203102

  • Joint prosthesis implantation kit, reusable

Cadence® - 10381780417125

Module for Pins, Drivers, and Accessories
Ascension Orthopedics, Inc.
CSA-1020-0015
In Commercial Distribution


  • 6.22in L x 5.08in W x 1.37in H
CSA-1020-0015

  • Instrument tray, reusable

Cadence® - 10381780417118

Size 5 Tibial Trial - Left
Ascension Orthopedics, Inc.
10204288
In Commercial Distribution


  • Size 5, L
10204288

  • Ankle prosthesis trial, reusable

Cadence® - 10381780417101

Size 4X Tibial Trial - Left
Ascension Orthopedics, Inc.
10204287
In Commercial Distribution


  • Size 4X, L
10204287

  • Ankle prosthesis trial, reusable

Cadence® - 10381780417095

Size 4 Tibial Trial - Left
Ascension Orthopedics, Inc.
10204286
In Commercial Distribution


  • Size 4, L
10204286

  • Ankle prosthesis trial, reusable

Cadence® - 10381780417088

Size 3X Tibial Trial - Left
Ascension Orthopedics, Inc.
10204285
In Commercial Distribution


  • Size 3X, L
10204285

  • Ankle prosthesis trial, reusable

Cadence® - 10381780417071

Size 3 Tibial Trial - Left
Ascension Orthopedics, Inc.
10204284
In Commercial Distribution


  • Size 3, L
10204284

  • Ankle prosthesis trial, reusable
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