Identity
- Trade Name
- Sterion® Vessel Loop FDA UDI
- Generic Name
- Surgical vessel loop FDA UDI
- Device Name
- Intended to be used to occlude, retract and identify arteries, veins, tendons and nerves in surgical procedures FDA UDI
- Model / Reference
- 011313PBX FDA UDI
- Description
- Intended to be used to occlude, retract and identify arteries, veins, tendons and nerves in surgical procedures FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840113229369 FDA UDI
- FDA Product Code
- KDC FDA UDI
- GMDN Term
- Surgical vessel loop FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical vessel loop
Sterion® Vessel Loop by Aspen Surgical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical vessel loop.
- Key Surgical Vascular Loops — Key Surgical, LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Devon — Cardinal Health 200, LLC · Class I
- Degania — DEGANIA SILICONE LTD · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aspen Surgical Products, Inc.
Sources (1)
- FDA UDI 642dadff-f321-42f0-96e6-de9f28f550fb 34 fields · synced Jun 9, 2026