AccessGUDID - DEVICE: Tor 3 Base Blue (07350075028939)

GUDID

Device Identifier (DI) Information

Brand Name: Tor 3 Base Blue
Version or Model: 8946
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Leloi AB

Primary DI Number: 07350075028939
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 508701849 *Terms of Use

Device Description: Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasure. The ring shall be able to be placed around the penis at the base, primarily to slow the flow of blood from the erect penile tissue, thus maintaining an erection for a much longer period of time. Plus a vibrator to facilitate human sexual pleasure.

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: b0271a61-883e-4fdb-99e3-b56e10b3972f
Public Version Date: July 04, 2023
Public Version Number: 1
DI Record Publish Date: June 26, 2023