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Bioseal Inc.

FDA UDI

Class I (US FDA UDI)

by Bioseal

Identity

Trade Name
Bioseal Inc. FDA UDI
Generic Name
Basic male condom, synthetic polymer FDA UDI
Device Name
Trojan Condom FDA UDI
Model / Reference
18296/25 FDA UDI
Description
Trojan Condom FDA UDI

Identifiers

Primary DI / UDI-DI
00630094829623 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Basic male condom, synthetic polymer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Basic male condom, synthetic polymer

Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic male condom, synthetic polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioseal

Sources (1)

  • FDA UDI f6c71f58-5c03-488c-aa7b-1e54f4b35660 33 fields · synced May 31, 2026