AccessGUDID - DEVICE: Cerafix® Dura Substitute (00854258006020)

GUDID

Device Identifier (DI) Information

Brand Name: Cerafix® Dura Substitute
Version or Model: C1-2X2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Acera Surgical Inc

Primary DI Number: 00854258006020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040631370 *Terms of Use

Device Description: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.

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?
58044	Dura mater graft, synthetic	A sterile device made from synthetic polymers [e.g., expanded polytetrafluoroethylene (ePTFE), ePTFE/elastic fluoropolymer) intended to be used for the temporary or permanent repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). This dural graft is typically overlaid on the patient's dura; it is typically supplied in the form of a patch and may be sutured into place.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXQ	Dura Substitute

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: Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.

Clinically Relevant Size

[?]

Size Type Text
Width: 5 Centimeter
Length: 5 Centimeter
Width: 2 Inch
Length: 2 Inch

Device Record Status

Public Device Record Key: 3e2bd854-9e7d-4600-8c41-348d3561cad0
Public Version Date: September 02, 2021
Public Version Number: 3
DI Record Publish Date: March 07, 2017