AccessGUDID - DEVICE: Prodisc L (00843193111791)

GUDID

Device Identifier (DI) Information

Brand Name: Prodisc L
Version or Model: PDL-M-SP06S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Centinel Spine, Inc.

Primary DI Number: 00843193111791
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 949024850 *Terms of Use
Previous DI: 10705034700175

Device Description: SUPERIOR END PLATE MEDIUM 6°-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?
48165	Lumbar total intervertebral disc prosthesis	An implantable device designed to replace a dysfunctional intervertebral disc in the lumbar spine. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below and may have a compressible core component between. It may facilitate some degree of motion and is typically made of metal and/or synthetic polymer materials. This is the complete prosthesis assembly, not individual components.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MJO	Prosthesis, Intervertebral Disc

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P050010	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: 621482f1-21e6-465d-a2a5-d43d1f570449
Public Version Date: April 21, 2021
Public Version Number: 3
DI Record Publish Date: October 16, 2018