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Hydro LeMaitre Valvulotome

FDA UDI

Class II (US FDA UDI)

by LeMaitre Vascular, Inc.

Identity

Trade Name
Hydro LeMaitre Valvulotome FDA UDI
Generic Name
Valvulotome FDA UDI
Device Name
Hydro LeMaitre Valvulotome (40 cm), eIFU FDA UDI
Model / Reference
e1010-00 FDA UDI
Description
Hydro LeMaitre Valvulotome (40 cm), eIFU FDA UDI

Identifiers

Catalog Number
e1010-00 FDA UDI
Primary DI / UDI-DI
00840663106837 FDA UDI
510(k) Number
K140042 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

Hydro LeMaitre Valvulotome by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Valvulotome.

Cleared under the same submission

K140042 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LeMaitre Vascular, Inc.

Sources (1)

  • FDA UDI 2c3002d1-9b7e-4eee-a580-50334f655095 36 fields · synced Jun 9, 2026