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SancDam™

FDA UDI

Class II (US FDA UDI)

by Sanctuary Health Sdn. Bhd.

Identity

Trade Name
SancDam™ FDA UDI
Generic Name
Oral/vaginal sex barrier, Hevea-latex FDA UDI
Device Name
Used as barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections FDA UDI
Model / Reference
OD001-S40-P103 FDA UDI
Description
Used as barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections FDA UDI

Identifiers

Primary DI / UDI-DI
09555514011383 FDA UDI
FDA Product Code
MSC FDA UDI
GMDN Term
Oral/vaginal sex barrier, 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

Yes

FDA UDI

Category: Oral/vaginal sex barrier, Hevea-latex

SancDam™ by Sanctuary Health Sdn. Bhd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/vaginal sex barrier, Hevea-latex.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sanctuary Health Sdn. Bhd.

Sources (1)

  • FDA UDI f22405c7-8f12-48dc-ad8b-05e401fdc564 33 fields · synced May 30, 2026