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Constriction Ring 12mm

FDA UDI

Class II (US FDA UDI)

by KESSEL medintim GmbH

Identity

Trade Name
Constriction Ring 12mm FDA UDI
Generic Name
Penile ring FDA UDI
Device Name
Constriction ring in 12mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction FDA UDI
Model / Reference
RIng 2 FDA UDI
Description
Constriction ring in 12mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction FDA UDI

Identifiers

Catalog Number
Ring 2 FDA UDI
Primary DI / UDI-DI
04013273000215 FDA UDI
FDA Product Code
LKY FDA UDI
GMDN Term
Penile ring FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Penile ring

Constriction Ring 12mm by KESSEL medintim GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Penile ring.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
KESSEL medintim GmbH

Sources (1)

  • FDA UDI 9a8d4d2e-752d-4061-ad54-28d84a213244 35 fields · synced May 30, 2026