AccessGUDID - DEVICE: Prodisc C (00843193112910)

GUDID

Device Identifier (DI) Information

Brand Name: Prodisc C
Version or Model: 09.820.076S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Centinel Spine, Inc.

Primary DI Number: 00843193112910
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 949024850 *Terms of Use
Previous DI: 10705034763880

Device Description: PRODISC-C IMPLANT EXTRA LARGE DEEP 6MM-STERILE

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
48164	Cervical total intervertebral disc prosthesis, modular	An implantable three-component assembly of devices intended to replace a dysfunctional intervertebral disc in the cervical spine that is comprised of an upper and lower endplate for attachment to adjacent vertebrae, and a space-occupying core between the plates to allow small movements of the adjacent vertebrae. The endplates are typically made of metal, and the core ceramic or synthetic polymer materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MJO	Prosthesis, Intervertebral Disc

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P070001	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8570c139-0955-4fe3-81dd-60e436c273f0
Public Version Date: April 21, 2021
Public Version Number: 4
DI Record Publish Date: October 16, 2018