DEVICE: Peri-Strips Dry with Veritas Collagen Matrix (00085412531809)
Device Identifier (DI) Information
Peri-Strips Dry with Veritas Collagen Matrix
PSD8002UDSTV
Not in Commercial Distribution
PSD8002UDSTV
SYNOVIS LIFE TECHNOLOGIES, INC.
PSD8002UDSTV
Not in Commercial Distribution
PSD8002UDSTV
SYNOVIS LIFE TECHNOLOGIES, INC.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47818 | 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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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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FTM | Mesh, surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
edb2bacd-62de-4ec8-8206-96cda7de29d4
July 27, 2023
3
October 05, 2015
July 27, 2023
3
October 05, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com