DEVICE: PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX CIRCULAR (00085412531298)
Device Identifier (DI) Information
PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX CIRCULAR
PSD21V
In Commercial Distribution
PSD21V
SYNOVIS LIFE TECHNOLOGIES, INC.
PSD21V
In Commercial Distribution
PSD21V
SYNOVIS LIFE TECHNOLOGIES, INC.
Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. The packaging contains a buttress assembly with two (2) circular buttresses, one for the anvil and one for the cartridge side of the stapler.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
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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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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
51deae47-f1ed-4b20-884e-a6c9483dc673
August 10, 2023
5
October 05, 2015
August 10, 2023
5
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