FDA.reportPublic FDA data

DUREX Avanti Bare- RealFeel Non-Latex Condom

Primary DI
88302340894560
Brand
DUREX Avanti Bare- RealFeel Non-Latex Condom
Company
RB Health (us) LLC
Model
Condom
Device description
Condom
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOLCondom, synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOLCondom, SyntheticObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072169000DUREX SYNTHETIC POLYISOPRENE MALE CONDOMSsl Americas, Inc.2008-06-19MOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10302340894569PackageGS13Not in Commercial Distribution
20302340894566PackageGS16Not in Commercial Distribution
88302340894560PrimaryGS10
40302340894560Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1030234089456910302340894569
2030234089456620302340894566
8830234089456088302340894560
4030234089456040302340894560

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat

Contacts#

Phone, Email table
PhoneEmail
+1(800)756-5488xxx@xxx.xxx

Regulatory Flags#

DUNS number
081049410
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00302340894555DUREX Real Feel Non-Latex Condom003023408945552025-03-13
00302340894579DUREX Real Feel Non-Latex Condom003023408945792025-03-13
00302340908054DUREX Real Feel Non-Latex Condom003023409080542025-03-13
00302340894562DUREX Real Feel Non-Latex Condom003023408945622025-03-13
00302340996136Durex Intense003023409961362026-03-02
50302340996131Durex Intense003023409961362026-03-02
00067981089127KY Personal Lubricant Jelly000679810891272025-12-09
00067981089486KY Warming Jelly 000679810894862025-12-09
00067981952292KY Intense Pleasure Gel000679819522922025-12-09
00067981993691KY Personal Lubricant Jelly000679819936912025-12-09
00067981993738KY Personal Lubricant Jelly000679819937382025-12-09
00067981993967KY Natural Feeling with Hyaluronic Acid000679819939672025-12-09
00067981993974KY Natural Feeling with Hyaluronic Acid000679819939742025-12-09
00067981993981KY Natural Feeling with Aloe Vera Lubricant000679819939812025-12-09
00067981087956KY Personal Lubricant Jelly000679810890282025-12-09
00067981087963KY Personal Lubricant Jelly000679810891272025-12-09
10067981088059KY Warming Jelly 000679810894792025-12-09
10067981088042KY Warming Jelly 000679810894862025-12-09
10067981993698KY Personal Lubricant Jelly000679819936912025-12-09
10067981993964KY Natural Feeling with Hyaluronic Acid000679819939672025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859798108526SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108533SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108540SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108632SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108724SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108465SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
08859798108472SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
08859798108496SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108462SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108479SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108493SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
00302340996136Durex IntenseRB Health (us) LLCMOL2026-03-02
50302340996131Durex IntenseRB Health (us) LLCMOL2026-03-02
08859798108441SKYNSURETEX LIMITED - BRANCHMOL2026-01-27
08859798108069SKYNSURETEX LIMITED - BRANCHMOL2026-01-13
18859798108066SKYNSURETEX LIMITED - BRANCHMOL2026-01-13
08859798107888SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107895SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107949SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107963SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107970SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108021SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108038SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108045SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108052SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
18859798107885SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
18859798107892SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798106973SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
08859798107307SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
08859798107314SKYNSURETEX LIMITED - BRANCHMOL2025-09-04