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Steamworks Non Lubricated

FDA UDI

Class II (US FDA UDI)

by Suretex Limited - Branch

Identity

Trade Name
STEAMWORKS NON LUBRICATED FDA UDI
Generic Name
Basic male condom, Hevea-latex FDA UDI
Device Name
STEAMWORKS NON LUBRICATED FDA UDI
Model / Reference
08859798104955 FDA UDI
Description
STEAMWORKS NON LUBRICATED FDA UDI

Identifiers

Primary DI / UDI-DI
08859798104955 FDA UDI
510(k) Number
K940046 FDA UDI
FDA Product Code
HIS FDA UDI
GMDN Term
Basic male condom, Hevea-latex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.5300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

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: Basic male condom, Hevea-latex

Steamworks Non Lubricated by Suretex Limited - Branch — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic male condom, Hevea-latex.

Cleared under the same submission

K940046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suretex Limited - Branch

Sources (1)

  • FDA UDI e88f53ec-6473-4031-b49c-b8ea0f3fcd05 35 fields · synced Jun 8, 2026