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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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PICASSO MIS Spinal System - 00841732109001

Cutter, Sleeve, Type 2
CTL Medical Corporation
016.7072
In Commercial Distribution

  • 00841732109001 ()


  • Orthopaedic implantable-device cutter

RAPHAEL - 00841732107809

Guide Pin, Type 2
CTL Medical Corporation
015.7002
In Commercial Distribution

  • 00841732107809 ()


  • Internal spinal fixation procedure kit, reusable

Dynex - 00841731125354

Post, 2 Hole Male
VILEX LLC
DSF-420-M2
In Commercial Distribution

  • 00841731125354 ()


  • External orthopaedic fixation system, single-use

GENERIC - 00841732141018

ADAPTOR, QC, EXTENSION, 2"
CTL Medical Corporation
100.2035
In Commercial Distribution

  • 00841732141018 ()


  • General internal orthopaedic fixation system implantation kit

ORIO - 00193082078330

ORIO-L Instrument Case 2
SPINECRAFT, LLC
7000-300
In Commercial Distribution

  • 00193082078330 ()
7000-300

  • General internal orthopaedic fixation system implantation kit

AIM MIS - 00193082052460

Dilator No.2, Anodized
SPINECRAFT, LLC
6100-52-N
In Commercial Distribution

  • 00193082052460 ()
6100-52-N

  • General internal orthopaedic fixation system implantation kit

APEX Spine System - 00193082051876

Uniplanar 2 Screw Caddy
SPINECRAFT, LLC
6000-620-2
In Commercial Distribution

  • 00193082051876 ()
6000-620-2

  • General internal orthopaedic fixation system implantation kit

ACS - 00191072000033

C-SECTION PACK 2 - 242901
AMERICAN CONTRACT SYSTEMS, INC.
AHCS77M
In Commercial Distribution

  • 00191072000033 ()


  • General surgical procedure kit, non-medicated, single-use

NA - 08800042404888

Rod Reducer 2 Adaptor
Medyssey Co., Ltd.
NCRA-001
Not in Commercial Distribution

  • 08800042404888 ()


  • Orthopaedic rod reducer

Centerline Thoracolumbar Spinal System - 00190837063962

Centerline Instrument Set 2
Life Spine, Inc.
114-542-A
In Commercial Distribution

  • 00190837063962 ()
114-542-A

  • Instrument tray, reusable
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