Identity
- Trade Name
- Symmetry Surgical FDA UDI
- Generic Name
- Valvulotome FDA UDI
- Device Name
- Symmetry® Valvulotome, Retrograde, 12 in FDA UDI
- Model / Reference
- 55-8682 FDA UDI
- Description
- Symmetry® Valvulotome, Retrograde, 12 in FDA UDI
Identifiers
- Catalog Number
- 55-8682 FDA UDI
- Primary DI / UDI-DI
- 00887482049952 FDA UDI
- 510(k) Number
- K022823 FDA UDI
- FDA Product Code
- MGZ FDA UDI
- GMDN Term
- Valvulotome FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4885 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDI
Category: Valvulotome
Symmetry Surgical by Symmetry Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Valvulotome.
- PILLING — TELEFLEX INCORPORATED · Class I
- Antegrade and Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc. · Class II
- PILLING — TELEFLEX INCORPORATED · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Antegrade and Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc. · Class II
- Over-the-Wire LeMaitre Valvulotome — LeMaitre Vascular, Inc. · Class II
- V. Mueller — STERIS CORPORATION · Class I
- Retrograde LeMills Valvulotome — LeMaitre Vascular, 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
- Symmetry Surgical Inc.
Sources (1)
- FDA UDI 6f6cff05-46e0-48cd-8996-27ea8873023a 37 fields · synced May 31, 2026