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Tru-Incise Valvulotome with Interchangeable Heads
FDA UDIClass II (US FDA UDI)
by Uresil Corp.
Identity
- Trade Name
- Tru-Incise Valvulotome with Interchangeable Heads FDA UDI
- Generic Name
- Vein stripper, single-use FDA UDI
- Device Name
- Tru-Incise 2mm Cutting Head FDA UDI
- Model / Reference
- TIVH20 FDA UDI
- Description
- Tru-Incise 2mm Cutting Head FDA UDI
Identifiers
- Catalog Number
- TIVH20 FDA UDI
- Primary DI / UDI-DI
- H862TIVH200 FDA UDI
- 510(k) Number
- K930011 FDA UDI
- FDA Product Code
- MGZ FDA UDI
- GMDN Term
- Vein stripper, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4885 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2 Micrometer FDA UDI
Tru-Incise Valvulotome with Interchangeable Heads by Uresil Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Uresil Corp.
Sources (1)
- FDA UDI 0a7e60da-1f27-4448-aa29-3842d57221ae 38 fields · synced May 30, 2026