AccessGUDID - DEVICE: PRESTIGE® Cervical Disc System (00721902440243)

GUDID

Device Identifier (DI) Information

Brand Name: PRESTIGE® Cervical Disc System
Version or Model: 6960015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00721902440243
Issuing Agency: GS1
Commercial Distribution End Date: October 08, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: SCREW 6960015 PRSTG BONE FAST 4.0X15MM

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61865	Cervical total disc replacement prosthesis, non-sterile	A non-sterile implantable device designed to replace most or all of a dysfunctional intervertebral disc in the cervical spine. It is made of synthetic polymer material(s) [e.g., polyetheretherketone (PEEK)] and typically has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below, to facilitate motion usually through the sliding action of its smooth surfaces. This device is intended to be sterilized before use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MJO	PROSTHESIS, INTERVERTEBRAL DISC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P060018	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
Width: 4.0 Millimeter
Length: 15.0 Millimeter

Device Record Status

Public Device Record Key: 5eca273e-9a15-4db8-8c73-7ff24eafc869
Public Version Date: August 30, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2014