Peri-Strips Dry with Veritas Collagen Matrix - Peri-Strips Dry with Veritas Collagen Matrix - SYNOVIS LIFE TECHNOLOGIES, INC.

Duns Number:017415781

Device Description: Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pe 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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More Product Details

Catalog Number

PSD9006UV

Brand Name

Peri-Strips Dry with Veritas Collagen Matrix

Version/Model Number

PSD9006UV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FTM

Product Code Name

Mesh, surgical

Device Record Status

Public Device Record Key

eaf41a0a-28ec-4ce2-9529-aeb918d9d24c

Public Version Date

October 11, 2022

Public Version Number

3

DI Record Publish Date

October 05, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNOVIS LIFE TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 135