One and FC2

FDA UDI

Class II (US FDA UDI)

by Global Protection Corp.

Identity

Trade Name: One and FC2 FDA UDI
Generic Name: Female condom, synthetic polymer FDA UDI
Device Name: FC2@Home Mailer w/Move 7 Internal Condoms, 5 Move Sachets FDA UDI
Model / Reference: 110100U-F FDA UDI
Description: FC2@Home Mailer w/Move 7 Internal Condoms, 5 Move Sachets FDA UDI

Identifiers

Primary DI / UDI-DI: 00726893115804 FDA UDI
FDA Product Code: MBU FDA UDI
NUC FDA UDI
GMDN Term: Female condom, synthetic polymer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5340 FDA UDI
884.5300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Sexual lubricant Female condom, synthetic polymer

One and FC2 by Global Protection Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Female condom, synthetic polymer.

Harmony Polyisoprene Dam Retail Pack — Pamco Distributing Inc · Class II
Harmony Latex Dam Bulk Box — Pamco Distributing Inc · Class II
Harmony Polyisoprene Dams Bulk Box — Pamco Distributing Inc · Class II
FC2 Female Condom® — Veru Inc. · Class II
Harmony Polyisoprene Single Sleeve — Pamco Distributing Inc · Class II
Harmony Latex Dam Retail Pack — Pamco Distributing Inc · Class II
FC2 — Veru Inc. · Class II
Harmony Latex Single Sleeve — Pamco Distributing Inc · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Global Protection Corp.

Sources (1)

FDA UDI 13ff9c37-364b-4251-ae0b-fbda37421167 35 fields · synced Jun 6, 2026