AccessGUDID - DEVICE: ENDOSKELETON® TCS (00191375028345)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSKELETON® TCS
Version or Model: 5210-1017
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5210-1017
Company Name: TITAN SPINE, LLC

Primary DI Number: 00191375028345
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: Graft Packing & Screw Reference Block

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?
47743	Bone graft packing block	A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.	Active	false

FDA Product Code

[?]

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
Height: 1 Inch
Width: 2 Inch
Length: 1.5 Inch

Device Record Status

Public Device Record Key: 3a044999-4442-4669-a003-f98a98944092
Public Version Date: December 09, 2020
Public Version Number: 4
DI Record Publish Date: September 30, 2019