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Valleylab

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Valleylab FDA UDI
Generic Name
Electrosurgical handpiece/electrode holder, single-use FDA UDI
Device Name
Accessory Holster FDA UDI
Model / Reference
E2400 FDA UDI
Description
Accessory Holster FDA UDI

Identifiers

Primary DI / UDI-DI
10884524000442 FDA UDI
510(k) Number
K791639 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrosurgical handpiece/electrode holder, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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: Electrosurgical handpiece/electrode holder, single-use

Valleylab by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical handpiece/electrode holder, single-use.

Cleared under the same submission

K791639 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 7fffa61c-c434-40a5-92e4-3b3c40d8cd42 36 fields · synced Jun 8, 2026