FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756029587
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
31-274
Device description
CONDOMS
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCONDOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756029587PackageGS150In Commercial Distribution
00749756029582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975602958750749756029587
00749756029582007497560295827497560295820749756029582

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, synthetic polymerA sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
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
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80028373140105WINK CLOSEROKAMOTO USA, INC.HIS2026-03-11
80028373149993WINK CLOSEROKAMOTO USA, INC.HIS2026-03-06
06925634004177AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
06925634004214AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
06925634004221AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
06925634004238AowawoSuzhou Colourway New Material Co., Ltd.HIS2026-03-02
80860014891508HUNKGLOBAL PROTECTION CORP.HIS2026-02-23
80860014891515Hunk WorldGLOBAL PROTECTION CORP.HIS2026-02-23
00860015047229Condom SenseGLOBAL PROTECTION CORP.HIS2026-02-23
10860015047233Condom senseGLOBAL PROTECTION CORP.HIS2026-02-23
04897041441680Smile Makers Come ConnectedRamblin Brands USA LLCHIS2026-02-13
18859798108073LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
18859798108080LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
00860014772207DOGTAG CONDOMSSuzhou Colourway New Material Co., Ltd.HIS2025-12-17
00860014772214DOGTAG CONDOMSSuzhou Colourway New Material Co., Ltd.HIS2025-12-17
09556807501949XO!RICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-15
18859798107878LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03
09556807500850GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
09556807500874GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
09556807500898GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
06977708230012ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
06977708230029ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
06977708230036ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
06977708230043ZIOXX Natural Rubber Latex Male CondomShaoguan Regenex Pharmaceutical Co., Ltd.HIS2025-11-24
00813356005014Crown Lubricated 500 ct BagPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005069Crown Lubricated 250 ct BagPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005137Kimono Bowl Microthin 40 ct BowlPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005205Crown Lubricated 100 ct BagPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-11-11
00813356005380Paradise Super Thin 100 CondomPARADISE MARKETING SERVICES, A CALIFORNIA CORPORATIONHIS2025-09-05
18859798107267LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04