FDA.reportPublic FDA data

Royal

Primary DI
00646437668859
Brand
Royal
Company
M3 Global Enterprises, LLC
Model
Royal Black Grape Condoms Box of 10
Published
2016-10-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161195000Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)M3 Global Enterprises, LLC2016-08-25HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00646437668859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00646437668859006464376688596464376688590646437668859

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, Hevea-latexA Hevea-latex rubber sheath 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

Regulatory Flags#

DUNS number
080373674
Device count
1
Lot or batch
true
Serial number
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
00850012584445RoyalRoyal Strawberry Condoms Box of 122024-01-01
00850012584001RoyalRoyal Natural Condoms Box of 32019-10-21
00850012584018RoyalRoyal Natural Condoms Box of 102019-10-21
00850012584100RoyalRoyal Strawberry Condoms Box of 102019-10-21
00850012584117RoyalRoyal Strawberry Condoms Box of 32019-10-21
00850012584124RoyalRoyal Strawberry Condoms Box of 202019-10-21
00850012584131RoyalRoyal Chocolate Condoms Box of 102019-10-21
00850012584148RoyalRoyal Chocolate Condoms Box of 32019-10-21
00850012584155RoyalRoyal Chocolate Condoms Box of 202019-10-21
00646437668811RoyalRoyal Natural Condoms Box of 202016-10-12
00646437668828RoyalRoyal Chocolate Condoms Box of 102016-10-12
00646437668835RoyalRoyal Strawberry Condoms Box of 102016-10-12
00646437668866RoyalRoyal Natural Condoms Box of 102016-10-12
00646437668873RoyalRoyal Chocolate Condoms Box of 32016-10-12
00646437668880RoyalRoyal Coffee Condoms Box of 32016-10-12
00646437668897RoyalRoyal Black Grape Condoms Box of 32016-10-12
00646437668903RoyalRoyal Natural Condoms Box of 32016-10-12
00646437668910RoyalRoyal Coffee Condoms Box of 202016-10-12
00646437668958RoyalRoyal Strawberry Condoms Box of 32016-10-12
00646437668989RoyalRoyal Chocolate Condoms Box of 202016-10-12

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