AccessGUDID - DEVICE: Rigicon Stainless Steel Dilator 09-10 mm (00850015358296)

GUDID

Device Identifier (DI) Information

Brand Name: Rigicon Stainless Steel Dilator 09-10 mm
Version or Model: RSSD-0910
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSSD-0910
Company Name: Rigicon, Inc.

Primary DI Number: 00850015358296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045247683 *Terms of Use

Device Description: Rigicon Stainless Steel Dilator 09-10 mm

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):	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?
60171	Corpus cavernosum dilator, reusable	A non-sterile, hand-held, manual surgical instrument designed to dilate the corpora cavernosa of the penis prior to the insertion of a penile prosthesis. The device is rod-like in design and typically made of metal (e.g., stainless steel); it is available in a set of graduated sizes that are applied in succession. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOA	Surgical Instruments, G-U, Manual (And Accessories)

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: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

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: d9b09e8e-bd72-47a6-aaa8-9817b2e4c45d
Public Version Date: February 12, 2024
Public Version Number: 1
DI Record Publish Date: February 02, 2024