PERI-GUARD repair patch PC1016NBIO

GUDID 00085412530604

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
Primary Device ID00085412530604
NIH Device Record Key49ee8da8-7df3-4bb0-a1e2-63f6900622d4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERI-GUARD repair patch
Version Model NumberPC1016N
Catalog NumberPC1016NBIO
Company DUNS017415781
Company NameSYNOVIS LIFE TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 0 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.Store at room temperature.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412530604 [Primary]

FDA Product Code

FTMMesh, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-08

On-Brand Devices [PERI-GUARD repair patch]

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

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