Suction Handpiece

FDA UDI

Class II (US FDA UDI)

by Lumenis

Identity

Trade Name: Suction Handpiece FDA UDI
Generic Name: Suction cannula, single-use FDA UDI
Model / Reference: Suction Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI: 07290109142104 FDA UDI
510(k) Number: K140388 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Suction cannula, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Suction cannula, single-use

Suction Handpiece by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K140388 also covers:

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: Lumenis

Sources (1)

FDA UDI 734a74f6-7374-4d6c-8971-cae5107a5c25 34 fields · synced May 30, 2026