AccessGUDID - DEVICE: Acanthus (00860005762620)

GUDID

Device Identifier (DI) Information

Brand Name: Acanthus
Version or Model: ACC019795
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ACC019795
Company Name: Acanthus Medical Creations LLC

Primary DI Number: 00860005762620
Issuing Agency: GS1
Commercial Distribution End Date: December 03, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 065124205 *Terms of Use

Device Description: Acanthus Condom Catheter Small-Medium with 3ml Skin Adhesive

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	Yes
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?
61504	Penis wearable urinal	An externally-worn urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag. The device is intended to provide an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention, and eliminates the need for groin and waist straps. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNY	Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile

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
Special Storage Condition, Specify: Standard room temperature conditions

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 21.98 Millimeter

Device Record Status

Public Device Record Key: c7746008-3570-4320-a3c9-2f596787f57f
Public Version Date: December 04, 2024
Public Version Number: 8
DI Record Publish Date: March 15, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10860005762627	30	00860005762620	2024-07-22	Not in Commercial Distribution	Box
20860005762624	50	00860005762620	2024-07-22	Not in Commercial Distribution	Box
30860005762621	10	00860005762620	2024-07-22	Not in Commercial Distribution	Box