SancDam™

GUDID 19555514001398

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

SANCTUARY HEALTH SDN. BHD.

Oral/vaginal sex barrier, Hevea-latex

• Primary Device ID: 19555514001398
• NIH Device Record Key: a912a0d2-62dc-4c25-afba-1004613e395d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SancDam™
• Version Model Number: OD001-S56-P103
• Company DUNS: 534420066
• Company Name: SANCTUARY HEALTH SDN. BHD.
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09555514001391 [Primary]
GS1	19555514001398 [Package]; Contains: 09555514001391; Package: [4 Units]; In Commercial Distribution
GS1	29555514001395 [Unit of Use]

FDA Product Code

• MSC: Barrier, Std, Oral Sex

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [SancDam™]

• 19555514011427: Mixed of 4 flavours of Vanilla, Grape, Strawberry and Mint. Assorted pack of 4 boxes. Used as b
• 19555514011410: Used as barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission
• 19555514011380: Used as barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission
• 19555514001404: Used as barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission
• 19555514001398: Used as barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission