AccessGUDID - DEVICE: Integra® DuraFlex® (10381780511366)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® DuraFlex®
Version or Model: BP10812
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BP10812
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780511366
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use
Previous DI: 10381780074243

Device Description: Integra® DuraFlex™ Suturable Dural Graft 8 cm x 12 cm

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: 12 Centimeter
Length: 8 Centimeter

Device Record Status

Public Device Record Key: 7eedc124-a5bc-4b11-b235-4f5471018d24
Public Version Date: May 16, 2023
Public Version Number: 5
DI Record Publish Date: February 22, 2019