Identity
- Trade Name
- Antegrade LeMills Valvulotome FDA UDI
- Generic Name
- Valvulotome FDA UDI
- Device Name
- Antegrade LeMills Valvulotome, eIFU FDA UDI
- Model / Reference
- e1050-01 FDA UDI
- Description
- Antegrade LeMills Valvulotome, eIFU FDA UDI
Identifiers
- Catalog Number
- e1050-01 FDA UDI
- Primary DI / UDI-DI
- 00840663107353 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
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
Category: Valvulotome
Antegrade LeMills Valvulotome by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K132047 also covers:
- Antegrade LeMills Valvulotome — LeMaitre Vascular, Inc.
- Antegrade and Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc.
- Antegrade and Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc.
- Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc.
- Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc.
K142660 also covers:
- Antegrade LeMills Valvulotome — LeMaitre Vascular, Inc.
- Antegrade and Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc.
- Antegrade and Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc.
- Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc.
- Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc.
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
- LeMaitre Vascular, Inc.
Sources (1)
- FDA UDI da5cb209-2e59-4b44-91c9-9532dd6de79d 36 fields · synced Jun 9, 2026