AccessGUDID - DEVICE: Integra® Bovine Pericardium Dural Graft (10381780074212)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Bovine Pericardium Dural Graft
Version or Model: BP10207
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BP10207
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780074212
Issuing Agency: GS1
Commercial Distribution End Date: February 22, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.

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?
45829	Dura mater graft, bovine	A xenograft made from bovine dura mater or bovine pericardium used for the 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 and resorbs within 9 to 12 months after surgery. It may be supplied in strips of various sizes and shapes (e.g., square or rectangular) and in a sterile, dry state with treated surfaces.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXQ	DURA SUBSTITUTE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132850	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
Special Storage Condition, Specify: Keep dry Keep away from sunlight
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 7 Centimeter
Length: 2 Centimeter

Device Record Status

Public Device Record Key: d3b50bc1-4215-4bf6-bb36-3dc5a2f8473f
Public Version Date: November 13, 2023
Public Version Number: 6
DI Record Publish Date: September 22, 2015