AccessGUDID - DEVICE: ENDOSKELETON® TAS (00191375020950)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSKELETON® TAS
Version or Model: 2312-0112-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2312-0112-S
Company Name: TITAN SPINE, LLC

Primary DI Number: 00191375020950
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623316978 *Terms of Use

Device Description: Interbody Fusion Device 12 Degree Standard 12mm

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:	Yes
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
Metallic spinal fusion cage, sterile	A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included.

GMDN Preferred Term Name

GMDN Definition

Metallic spinal fusion cage, sterile

A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included.

FDA Product Code

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Product Code	Product Code Name
OVD	Intervertebral fusion device with integrated fixation, lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111626	000
K142589	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 12 Millimeter
Device Size Text, specify: Lordotic Angle 12 Deg
Device Size Text, specify: 32 x 21 (M/L x A/P) mm

Device Record Status

Public Device Record Key: 53803340-448e-4547-ad3a-f7f227571def
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 15, 2016