AccessGUDID - DEVICE: Rigicon HL Dilator 15

GUDID

Device Identifier (DI) Information

Brand Name: Rigicon HL Dilator 15 – 16 mm
Version or Model: RSUD-1516
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSUD-1516
Company Name: Rigicon, Inc.

Primary DI Number: 00850015358432
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045247683 *Terms of Use

Device Description: Rigicon HL Dilator 15 – 16 mm Disposable

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:	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?
60798	Penile prosthesis implantation instrument	A sterile, hand-held manual surgical instrument intended to be used to implant a penile prosthesis (e.g., penile prosthesis cylinder insertion within the corpora cavernosa). It may also be used during revision surgery of a penile prosthesis; it has no general surgical application. This is a single-use 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: Yes
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: 9e618a7c-4960-448c-932c-d89178057212
Public Version Date: February 12, 2024
Public Version Number: 1
DI Record Publish Date: February 02, 2024