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Smoothkit+

FDA UDI

Class II (US FDA UDI)

by LSO Medical

Identity

Trade Name
SMOOTHKIT+ FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
STERILE MEDICAL HANDPIECE FOR SINGLE USE FDA UDI
Model / Reference
SK+-EO-980-25-600-3 FDA UDI
Description
STERILE MEDICAL HANDPIECE FOR SINGLE USE FDA UDI

Identifiers

Primary DI / UDI-DI
03760227850198 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, 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

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: General surgical procedure kit, non-medicated, single-use

Smoothkit+ by LSO Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LSO Medical

Sources (1)

  • FDA UDI 90f7848d-037e-4da9-a600-9659665a6159 35 fields · synced May 30, 2026