AccessGUDID - DEVICE: DuraGen® Plus (10381780070948)

GUDID

Device Identifier (DI) Information

Brand Name: DuraGen® Plus
Version or Model: DP5033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DP-5033
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780070948
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: DuraGen® Plus Dural Regeneration Matrix, 3 in x 3 in (7.5 cm x 7.5 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 [?]
K032693	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: Store at room temperature. Avoid excessive hat or humidty. Do not refrigerate.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3 in x 3 in 7.5 cm x 7.5 cm

Device Record Status

Public Device Record Key: 1da1f887-fca2-4bfb-8b83-8501b5828bef
Public Version Date: April 14, 2023
Public Version Number: 8
DI Record Publish Date: September 22, 2015