Identity
- Trade Name
- PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP FDA UDI
- Generic Name
- Staple line-reinforcement strip FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- PSDA45ECHTHN FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- PSDA45ECHTHN FDA UDI
- Primary DI / UDI-DI
- 00085412658858 FDA UDI
- 510(k) Number
- K192615 FDA UDI
- FDA Product Code
- FTM FDA UDIOXE FDA UDI
- GMDN Term
- Staple line-reinforcement strip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDI
Category: Staple line-reinforcement strip
Peri-Strips Dry With Veritaswith Secure Grip by Synovis Life Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Peri-Strips Dry with Veritas Collagen Matrix — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synovis Life Technologies, Inc.
Sources (1)
- FDA UDI 623cf9a7-dd20-435d-a9ea-2447dd38d15f 38 fields · synced May 30, 2026