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Skyn

FDA UDI

Class II (US FDA UDI)

by Lil Drug Store Products, Inc.

Identity

Trade Name
SKYN FDA UDI
Generic Name
Basic male condom, synthetic polymer FDA UDI
Device Name
SKYN Original Non-Latex Condom,3ct FDA UDI
Model / Reference
210100 FDA UDI
Description
SKYN Original Non-Latex Condom,3ct FDA UDI

Identifiers

Catalog Number
90200 FDA UDI
Primary DI / UDI-DI
00792554902007 FDA UDI
510(k) Number
K171172 FDA UDI
FDA Product Code
MOL FDA UDI
GMDN Term
Basic male condom, synthetic polymer 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

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Basic male condom, synthetic polymer

Skyn by Lil Drug Store Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic male condom, synthetic polymer.

Cleared under the same submission

K171172 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lil Drug Store Products, Inc.

Sources (1)

  • FDA UDI 3a645c02-2c63-4a4f-bef5-d14195e29036 35 fields · synced May 30, 2026