AccessGUDID - DEVICE: ENDOSKELETON® TCS (00191375011859)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSKELETON® TCS
Version or Model: 5210-1005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5210-1005
Company Name: TITAN SPINE, LLC

Primary DI Number: 00191375011859
Issuing Agency: GS1
Commercial Distribution End Date: September 18, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 623316978 *Terms of Use

Device Description: Swivel Driver, No 8 Hexalobe

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12696	Orthopaedic implant inserter/extractor, reusable	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) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral fusion device with bone graft, cervical
OVE	Intervertebral fusion device with integrated fixation, 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
Length: 5 Inch

Device Record Status

Public Device Record Key: 10babd26-1355-48f8-a811-ac31d89060aa
Public Version Date: December 09, 2020
Public Version Number: 10
DI Record Publish Date: December 15, 2016