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Durex Extra Sensitive Close Fit Condom

FDA UDI

Class II (US FDA UDI)

by RB Health (us) LLC

Identity

Trade Name
Durex Extra Sensitive Close Fit Condom FDA UDI
Generic Name
Basic male condom, Hevea-latex FDA UDI
Device Name
Condom FDA UDI
Model / Reference
Condom FDA UDI
Description
Condom FDA UDI

Identifiers

Primary DI / UDI-DI
88302340876504 FDA UDI
510(k) Number
K980319 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
Not 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Durex Extra Sensitive Close Fit Condom by RB Health (us) LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K980319 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
RB Health (us) LLC

Sources (1)

  • FDA UDI 889fb706-18bc-494d-97df-78992c679d36 37 fields · synced May 30, 2026