FDA.reportPublic FDA data

Harmony non-Latex Dam

Primary DI
00726893120587
Brand
Harmony non-Latex Dam
Company
GLOBAL PROTECTION CORP.
Model
PHA101R
Device description
non-latex prophylactic Dam
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

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
20726893120581PackageGS1100In Commercial Distribution
00726893120587PrimaryGS10
80726893120583Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2072689312058120726893120581
00726893120587007268931205877268931205870726893120587
8072689312058380726893120583

GMDN Terms#

Term, Definition table
TermDefinition
Female condom, synthetic polymerA sheath made of synthetic polymers (e.g., polyurethane or nitrile) with rings on either end that is inserted into the vagina before coitus to prevent sperm from gaining access to the female reproductive tract and/or to prevent the transmission of sexually transmitted infections (STI) between sexual partners. It typically includes a lubricant to minimize friction during coitus. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place. Avoid excessive heat.

Contacts#

Phone, Email table
PhoneEmail
6179462800ccataldo@globalprotection.com

Regulatory Flags#

DUNS number
364614362
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00726893120754TrustexTXD05U2026-06-04
00726893120761Super sensitiveCRDF-62026-06-04
20726893120482Mixed Pleasure110109C2026-06-04
20726893120710Glowing Pleasures11500BC2026-06-04
20726893120574One Super sensitive11600CY2026-04-28
20726893120673One Classic Select11000BYC2026-04-28
20726893120680One Classic Select11000BC2026-04-28
20726893120697One Flavorwaves110200BC2026-04-28
20726893120703One Legend11400BC2026-04-28
20726893120468One Ultra Feel112309C2026-04-24
20726893120475One Flex1131009C2026-04-24
20726893120499One Super Studs111709C2026-04-24
20726893120505One Vanish111309C2026-04-24
20726893120512One Pleasure Plus110309C2026-04-24
20726893120529One Super Sensitive11609C2026-04-24
20726893120536ONE Flavorwaves110209C2026-04-24
20726893120543One Legend11409C2026-04-24
20726893120550One Tattoo Touch112009C2026-04-24
20726893120567One Glowing Pleasures11509C2026-04-24
38858693803605AHF Impulse XL99AHF22C2026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00860008392145LoralsBrazen Goods Inc.MSC2022-08-12
00860008392152LoralsBrazen Goods Inc.MSC2022-08-12
00860008392138LoralsBrazen Goods Inc.MSC2022-08-12
00860008392121LoralsBrazen Goods Inc.MSC2022-08-12