FDA.reportPublic FDA data

SancDam™

Primary DI
09555514012991
Brand
SancDam™
Company
SANCTUARY HEALTH SDN. BHD.
Model
OD001-S62-P284
Device description
Mixed of 4 flavours of Vanilla, Grape, Strawberry and Mint. Assorted pack of 8 pcs. Used as barrier when engaging in oral/vaginal and oral/anal sex against sexually transmitted diseases
Published
2025-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MSCBarrier, Std, Oral Sex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSCBarrier, Std, Oral SexObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09555514012991PrimaryGS10
29555514012995Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09555514012991095555140129919555514012991
2955551401299529555514012995

GMDN Terms#

Term, Definition table
TermDefinition
Oral/vaginal sex barrier, Hevea-latexA device in the form of a flat sheet (a rubber dam), composed of Hevea-latex, designed to help reduce the risk of catching/spreading sexually transmitted infections (STI), also known as sexually transmitted diseases (STD), such as syphilis, gonorrhoea, Chlamydia infections, genital herpes, and acquired immune deficiency syndrome (AIDS ) during oral-vaginal sexual activity. It is placed over the entire vulva, covering both the vaginal opening and the clitoris, or alternatively, over the entire anal area, including the anus. It is held in place by one of the sexual partners and may be moistened with a commercially available lubricant to enhance performance. This is a single-use device.

Regulatory Flags#

DUNS number
534420066
Device count
8
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
29555514012995SancDam™OD001-S62-P2842025-02-13
09555514001391SancDam™OD001-S56-P1032023-10-20
09555514001407SancDam™OD001-S38-P1032023-10-20
09555514011383SancDam™OD001-S40-P1032023-10-20
09555514011413SancDam™OD001-S20-P1032023-10-20
09555514011420SancDam™OD001-S62-P1032023-10-20
19555514001398SancDam™OD001-S56-P1032023-10-20
19555514001404SancDam™OD001-S38-P1032023-10-20
19555514011380SancDam™OD001-S40-P1032023-10-20
19555514011410SancDam™OD001-S20-P1032023-10-20
19555514011427SancDam™OD001-S62-P1032023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120594Harmony Latex DamGLOBAL PROTECTION CORP.MSC2026-06-08
00726893120600harmony Non- Latex damsGLOBAL PROTECTION CORP.MSC2026-06-08
00726893120617Harmony Latex DamsGLOBAL PROTECTION CORP.MSC2026-06-08
00726893120587Harmony non-Latex DamGLOBAL PROTECTION CORP.MSC2026-06-04
29555514012995SancDam™SANCTUARY HEALTH SDN. BHD.MSC2025-02-13
00726893118324LTS Safer Sex KitGLOBAL PROTECTION CORP.MSC2025-01-06
00726893118416Custom CondomsGLOBAL PROTECTION CORP.MSC2025-01-06
00628347062736Harmony Latex Single SleevePamco Distributing IncMSC2024-05-30
00628347062774Harmony Polyisoprene Single SleevePamco Distributing IncMSC2024-05-30
09555514001391SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
09555514001407SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
09555514011383SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
09555514011413SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
09555514011420SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514001398SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514001404SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514011380SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514011410SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514011427SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
00726893114913Satin DamsGLOBAL PROTECTION CORP.MSC2023-07-07
00726893115101Satin DamsGLOBAL PROTECTION CORP.MSC2023-07-07
80726893114919Satin DamsGLOBAL PROTECTION CORP.MSC2023-07-07
80726893115107Satin DamsGLOBAL PROTECTION CORP.MSC2023-07-07
00850049875004LoralsBrazen Goods Inc.MSC2023-02-04
00850049875011LoralsBrazen Goods Inc.MSC2023-02-04
00860008392183LoralsBrazen Goods Inc.MSC2023-02-04
00860008392190LoralsBrazen Goods Inc.MSC2023-02-04
00860008392169LoralsBrazen Goods Inc.MSC2022-12-19
00860008392176LoralsBrazen Goods Inc.MSC2022-12-19
00860008392145LoralsBrazen Goods Inc.MSC2022-08-12