DEVICE: DURA-GUARD Dural Repair Patch (00085412530956)

Device Identifier (DI) Information

DURA-GUARD Dural Repair Patch
DG0209SN
In Commercial Distribution
DG0209SN
SYNOVIS LIFE TECHNOLOGIES, INC.
00085412530956
GS1

1
017415781 *Terms of Use
Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Dura-Guard is chemically sterilized using ethanol and propylene oxide. Dura-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Dura-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GXQ DURA SUBSTITUTE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: more than 32 Degrees Fahrenheit
Special Storage Condition, Specify: Do not freeze.Store at room temperature.
Storage Environment Temperature: more than 0 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

7618cc67-85cd-493d-91a0-75b36bad55c4
March 29, 2018
2
October 08, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
CLOSE