AccessGUDID - DEVICE: ENDOSKELETON® TCS (00191375011866)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSKELETON® TCS
Version or Model: 5210-1010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5210-1010
Company Name: TITAN SPINE, LLC

Primary DI Number: 00191375011866
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623316978 *Terms of Use

Device Description: AWL GUIDE

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 implantation sleeve, reusable	A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic implantation sleeve, reusable

A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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: 462ab67f-e1ea-4492-88f3-0ee0f0a46edb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 15, 2016