AccessGUDID - DEVICE: RIGI10 (00850299008450)

GUDID

Device Identifier (DI) Information

Brand Name: RIGI10
Version or Model: RG1011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RG1011
Company Name: Rigicon, Inc.

Primary DI Number: 00850299008450
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045247683 *Terms of Use
Previous DI: 00850299008023

Device Description: DIAMETER:11MM MALLEABLE PENILE PROSTHESIS

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
Prescription Use (Rx):	Yes
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?
36251	Rigid penile prosthesis	A rigid or semi-rigid sterile rod or cylinder-like device intended to be surgically implanted in the corpora cavernosa of the penis in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve permanent penile tumescence and rigidity adequate for vaginal intercourse. This device is available in a variety of designs and materials such as: 1) a flexible solid rod of polymer; 2) a flexible polymer or silicone cylinder with an internal silver (Ag) coil core; or 3) a single- or multiple-hinged rod enabling the user to position the penis downwards for better concealment under clothing.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FAE	Prosthesis, Penile

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 11 Millimeter

Device Record Status

Public Device Record Key: ab2febe5-975b-438f-bbdb-4af0deb0bad8
Public Version Date: February 05, 2024
Public Version Number: 1
DI Record Publish Date: January 26, 2024