FDA.reportPublic FDA data

Lorals

Primary DI
00860008392152
Brand
Lorals
Company
Brazen Goods Inc.
Model
Shortie
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00860008392152PrimaryGS10
00860008392121Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008392152008600083921528600083921520860008392152
00860008392121008600083921218600083921210860008392121

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
128095084
Device count
50
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049875004LoralsBikini2023-02-04
00850049875011LoralsShortie2023-02-04
00860008392183LoralsBikini2023-02-04
00860008392190LoralsShortie2023-02-04
00860008392169LoralsBikini2022-12-19
00860008392176LoralsShortie2022-12-19
00860008392145LoralsBikini2022-08-12
00860008392138LoralsBikini2022-08-12
00860008392121LoralsShortie2022-08-12
00860008392107LoralsBikini2022-04-29
00860008392114LoralsShortie2022-04-29

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
09555514012991SancDam™SANCTUARY HEALTH SDN. BHD.MSC2025-02-13
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