AccessGUDID - DEVICE: Constriction Ring 12mm (04013273000215)

GUDID

Device Identifier (DI) Information

Brand Name: Constriction Ring 12mm
Version or Model: RIng 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Ring 2
Company Name: KESSEL medintim GmbH

Primary DI Number: 04013273000215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 537500365 *Terms of Use

Device Description: Constriction ring in 12mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46334	Penile ring	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKY	Device, External Penile Rigidity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a8d4d2e-752d-4061-ad54-28d84a213244
Public Version Date: August 04, 2022
Public Version Number: 1
DI Record Publish Date: July 27, 2022