AccessGUDID - DEVICE: ENDOSKELETON® TCS (00191375011842)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSKELETON® TCS
Version or Model: 5210-1004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5210-1004
Company Name: TITAN SPINE, LLC

Primary DI Number: 00191375011842
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623316978 *Terms of Use

Device Description: NO 8 HEXALOBE, STRAIGHT DRIVER

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Orthopaedic implant inserter/extractor	A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) into or out of the body. It is a robust instrument that has a mechanism (e.g., a sturdy hook that slots into one of the nail's locking screw holes, or a tapered/straight thread that locks into the inner material/thread of the implant's construct, or a clamp that will attach and/or lock to an exposed part of the implant). It is typically made of stainless steel/synthetic material and the surgeon can make strikes on the proximal end with a surgical hammer or mallet to insert/extract the implant. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic implant inserter/extractor

A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) into or out of the body. It is a robust instrument that has a mechanism (e.g., a sturdy hook that slots into one of the nail's locking screw holes, or a tapered/straight thread that locks into the inner material/thread of the implant's construct, or a clamp that will attach and/or lock to an exposed part of the implant). It is typically made of stainless steel/synthetic material and the surgeon can make strikes on the proximal end with a surgical hammer or mallet to insert/extract the implant. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
OVE	Intervertebral fusion device with integrated fixation, cervical
ODP	Intervertebral fusion device with bone graft, cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142940	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ccbfb2e6-d1c0-4283-9c64-f2c0c5f922d4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 15, 2016