Peri-Strips Dry with Veritas Collagen Matrix Circular

Basic Information

• Brand Name: Peri-Strips Dry with Veritas Collagen Matrix Circular
• Primary DI: 00085412531281
• Version / Model: PSD21EV
• Catalog Number: PSD21EVBIO
• Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.
• Labeler DUNS: 017415781
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-05
• Public Version: 3
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: 0bc32dc8-6e36-44fc-9b93-ae5f6545f0be
• Distribution End Date: 2016-10-31

Device Description

Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) Circular Staple Line Reinforcement is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. The packaging contains two loading units w/buttress material, one for the anvil and one for the cartridge side of the stapler. The packaging also includes one cartridge cone to aid atraumatic advancement of the stapler into the surgical site, and one tube of PSD Gel to create a temporary bond between the buttress and the surgical stapler until the stapler is positioned and fired.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTM	Mesh, surgical	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00085412531281	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius