DURA-GUARD Dural Repair Patch DG0608SN

GUDID 00085412531007

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

SYNOVIS LIFE TECHNOLOGIES, INC.

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• Primary Device ID: 00085412531007
• NIH Device Record Key: 206f768a-fd06-46ca-842a-935e839ba88d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURA-GUARD Dural Repair Patch
• Version Model Number: DG0608SN
• Catalog Number: DG0608SN
• Company DUNS: 017415781
• Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412531007 [Primary]

FDA Product Code

• GXQ: DURA SUBSTITUTE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-08

On-Brand Devices [DURA-GUARD Dural Repair Patch]

• 00085412531045: Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pe
• 00085412531021: Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pe
• 00085412531007: Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pe
• 00085412530987: Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pe
• 00085412530956: Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pe