FDA.reportPublic FDA data

Harmony Latex Dam Bulk Box

Primary DI
00860003804513
Brand
Harmony Latex Dam Bulk Box
Company
Pamco Distributing Inc
Model
HA-202
Device description
Harmony Latex Dam Bulk Box 100/box
Published
2022-02-17
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

Product Codes#

Code, Name table
CodeName
MSCBarrier, Std, Oral Sex

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203727000Harmony Latex Dam, Harmony Non-Latex DamPamco Distributing, Inc.2021-08-05MSC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003804513PrimaryGS10
00860003804551Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003804513008600038045138600038045130860003804513
00860003804551008600038045518600038045510860003804551

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
208394130
Device count
100
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628347063863UltuCup Box Model 2 EN/FR/ESModel 22024-08-16
00628347063870UltuCup Box Model 1 EN/FR/ESModel 12024-08-16
00628347063894UltuCup Box Model 0 EN/FR/ESModel 02024-08-14
00628347062736Harmony Latex Single SleeveHA-202-INS2024-05-30
00628347062774Harmony Polyisoprene Single SleeveHA-101-INSREV C2024-05-30
00628347065553Harmony Polyisoprene Dams Bulk Box HA-1012022-02-17
00628347062729Harmony Latex Dam Bulk BoxHA-202 2022-02-17
00628347065881Harmony Polyisoprene Dam Retail Pack HA-101-R2022-02-17
00628347069810Harmony Latex Dam Retail PackHA-202-R2022-02-17
00860003804544Harmony Polyisoprene Dams Bulk Box HA-1012022-02-17
00860003804520Harmony Polyisoprene Dam Retail Pack HA-101-R2022-02-17
00860003804537Harmony Latex Dam Retail PackHA-202-R2022-02-17

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