AccessGUDID - DEVICE: DuraGen® Plus (10381780023456)

GUDID

Device Identifier (DI) Information

Brand Name: DuraGen® Plus
Version or Model: DP1022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DP-1022
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780023456
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, 2 in x 2 in (5 cm x 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?
48155	Dura mater biomatrix implant	A bioabsorbable device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). The device is typically in the form of a transparent foil that usually requires no suturing and may be used with fibrin sealant.	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: 2 in x 2 in 5 cm x 5 cm

Device Record Status

Public Device Record Key: c3c1d655-d705-403c-b8f9-772180aabc83
Public Version Date: April 14, 2023
Public Version Number: 7
DI Record Publish Date: September 22, 2015