PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP

Basic Information

• Brand Name: PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP
• Primary DI: 00085412658797
• Version / Model: PSDA45ECH
• Catalog Number: PSDA45ECH
• Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.
• Labeler DUNS: 017415781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-23
• Public Version: 8
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: 461564f1-8b40-49a5-bb15-2b97a62d3770

Device Description

PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe.

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OXE	Mesh, surgical, collagen, staple line reinforcement	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
Package	50085412658792	GS1	CASE	6	In Commercial Distribution
Primary	00085412658797	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192615	000

Device Sizes

Type	Value	Unit	Text
Length	45	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius