DEVICE: Peri-Strips Dry with Veritas Collagen Matrix (00085412531502)

Device Identifier (DI) Information

Peri-Strips Dry with Veritas Collagen Matrix
PSD4502ECHV
Not in Commercial Distribution
PSD4502ECHV
SYNOVIS LIFE TECHNOLOGIES, INC.
00085412531502
GS1
October 31, 2016
1
017415781 *Terms of Use
Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD-V. The Gel is used to create a temporary bond between the PSD-V buttress and the surgical stapler jaws until the stapler is positioned and fired.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Staple line-reinforcement strip A sterile bioabsorbable device made of material derived from animal tissue intended to buttress staple lines and control leaks of blood, fluids, and air from around staple lines typically during cardiothoracic and abdominal surgeries. It is typically available as strips of material provided with an adhesive hydrogel to facilitate rehydration of the strips and their temporary adherence to the stapler loader unit before application of the staples with the strips to the tissue. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FTM Mesh, surgical
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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: between 68 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2ef7bb89-8048-4ee1-96f2-6ffcb1fdfc20
March 29, 2018
2
October 05, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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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