PERI-GUARD repair patch PC0404NBIO

GUDID 00085412530529

Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.

SYNOVIS LIFE TECHNOLOGIES, INC.

Multi-purpose surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived

• Primary Device ID: 00085412530529
• NIH Device Record Key: 5897cf21-da67-421e-b61a-04852d1918f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERI-GUARD repair patch
• Version Model Number: PC0404N
• Catalog Number: PC0404NBIO
• 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
• 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
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.Store at room temperature.
• 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.
• 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
• 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	00085412530529 [Primary]

FDA Product Code

• DXZ: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

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 [PERI-GUARD repair patch]

• 00085412530628: Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross
• 00085412530604: Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross
• 00085412530581: Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross
• 00085412530567: Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross
• 00085412530529: Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross