AccessGUDID - DEVICE: Mobi-C® Plug & Fit US (03662663000154)

GUDID

Device Identifier (DI) Information

Brand Name: Mobi-C® Plug & Fit US
Version or Model: MB3575
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LDR Spine Usa, Inc.

Primary DI Number: 03662663000154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 615789729 *Terms of Use

Device Description: Total Cervical Disc Replacement System: Mobi-C Cervical Disc Prosthesis

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 [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Keep dry, protect from sunlight

Clinically Relevant Size

[?]

Size Type Text
Height: 5 Millimeter
Width: 17 Millimeter
Depth: 15 Millimeter

Device Record Status

Public Device Record Key: 136981fc-34e9-4a6f-837d-691535a67595
Public Version Date: January 03, 2025
Public Version Number: 8
DI Record Publish Date: September 24, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 512-344-3333
Email: surgeoninfo@ldrspine.com

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