DEVICE: SUPPLE PERI-GUARD pericardium (00085412530697)

Device Identifier (DI) Information

SUPPLE PERI-GUARD pericardium
PC0814SN
In Commercial Distribution
PC0814SNBIO
SYNOVIS LIFE TECHNOLOGIES, INC.
00085412530697
GS1

1
017415781 *Terms of Use
Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile
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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
Multi-purpose surgical mesh, collagen, non-bioabsorbable A sterile, non-bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction, pericardial closure, great vessel repair]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
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FDA Product Code

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Product Code Product Code Name
DXZ PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
OXB Mesh, surgical, collagen, thoracic, chest wall reconstruction
FTM Mesh, surgical
OWV Mesh, surgical, collagen, diaphragmatic hernia
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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
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: more than 0 Degrees Celsius
Storage Environment Temperature: more than 32 Degrees Fahrenheit
Special Storage Condition, Specify: Do not freeze.Store at room temperature.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1cfce202-cd06-4db1-9474-c86eb5307573
March 29, 2018
2
October 08, 2015
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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