AccessGUDID - DEVICE: SCARLET® AC-T Secured Anterior Cervical Cage (07640151088644)

GUDID

Device Identifier (DI) Information

Brand Name: SCARLET® AC-T Secured Anterior Cervical Cage
Version or Model: SCA-AC LL 08-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCA-AC LL 08-S
Company Name: SpineArt SA

Primary DI Number: 07640151088644
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483016148 *Terms of Use

Device Description: Secured Lordotic Anterior Cervical Cage / Large

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?
38161	Metallic spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 17 Millimeter
Height: 8 Millimeter
Depth: 14 Millimeter

Device Record Status

Public Device Record Key: e8e71bba-bb75-42b9-b342-cae8c56227fd
Public Version Date: March 31, 2025
Public Version Number: 7
DI Record Publish Date: October 01, 2015