Peri-Strips Dry with Veritas PSDA45GIA

GUDID 50085412658686

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.

SYNOVIS LIFE TECHNOLOGIES, INC.

Staple line-reinforcement strip

• Primary Device ID: 50085412658686
• NIH Device Record Key: 1ef32cbb-bca7-4449-9d27-ac5183753422
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peri-Strips Dry with Veritas
• Version Model Number: PSDA45GIA
• Catalog Number: PSDA45GIA
• Company DUNS: 017415781
• Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com

Device Dimensions

• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412658681 [Primary]
GS1	50085412658686 [Package]; Contains: 00085412658681; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213125

FDA Product Code

• OXE: Mesh, surgical, collagen, staple line reinforcement

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-29
• Device Publish Date: 2024-11-21

On-Brand Devices [Peri-Strips Dry with Veritas]

• 50085412658839: PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of a
• 50085412658686: PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of a