FDA.reportPublic FDA data

Constriction Ring 18mm

Primary DI
04013273000239
Brand
Constriction Ring 18mm
Company
KESSEL medintim GmbH
Model
RIng 4
Catalog number
Ring 4
Device description
Constriction ring in 18mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction
Published
2022-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKYDevice, External Penile Rigidity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKYDevice, External Penile RigidityGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04013273000239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04013273000239040132730002394013273000239

GMDN Terms#

Term, Definition table
TermDefinition
Penile ringA device intended to be applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for vaginal intercourse. It is typically designed as a flexible rubber loop that is placed on the penis (i.e., around its base) to restrict the flow of venous blood leaving the penis during an erection. This device can be used alone or with a penile vacuum pump. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+496105203720export@medintim.de

Regulatory Flags#

DUNS number
537500365
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04013273000116Active Erection SystemAES 012019-01-21
04013273001557Vagiwell Dilator 5er Set PremiumVagiwell PVagiwell P2023-07-20
04013273001564Vaginal Dilator 3er Set smallVagiwell SVagiwell S2023-07-20
04013273001571Vaginal Dilator 3er Set largeVagiwell LVagiwell L2023-07-20
04013273000208Constriction Ring 9mmRIng 1Ring 12022-07-27
04013273000215Constriction Ring 12mmRIng 2Ring 22022-07-27
04013273000222Constriction Ring 15mmRIng 3Ring 32022-07-27
04013273000246Constriction Ring 21mmRIng 5Ring 52022-07-27
04013273001175Manual Erection SystemMES 01MES 012021-11-19
04013273001915Active3 Erection SystemAES 3AES 32020-01-29
04013273001649Caya contoured diaphragmCaya contoured diaphragmDIA CAYA USA2017-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00850076064068Pump Worx Beginner's Vibrating Pump - Clear/Black PD Products, LLCLKY2026-05-01
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00850076064136Pump Worx Beginner's Power Pump - Purple PD Products, LLCLKY2026-05-01
00850076064143Pump Worx Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
00850076064150Classix Power PumpPD Products, LLCLKY2026-05-01
00850076064167Pump Worx Beginner's Power Pump - Red PD Products, LLCLKY2026-05-01
00850076064174Classix Vibrating Power Pump - ClearPD Products, LLCLKY2026-05-01
00850076064181Pump Worx Beginner's Power Pump - Smoke/Black PD Products, LLCLKY2026-05-01
00850076064198Pump Worx Pistol-Grip Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064204Pump Worx Max-Width Penis Enlarger - Clear/Black PD Products, LLCLKY2026-05-01
00850076064211Pipedream Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
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