AccessGUDID - DEVICE: SureStep Male External Catheter System (00801741183638)

GUDID

Device Identifier (DI) Information

Brand Name: SureStep Male External Catheter System
Version or Model: MECSM010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MECSM010
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741183638
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: SureStep Male External Catheter System - Starter Kit with 350ml Urine Meter and 2500ml Urine Collection Bag

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:	Yes
Prescription Use (Rx):	No
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?
34929	Urinary incontinence penis sheath/port, single-use	A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. 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
NNX	DEVICE, INCONTINENCE, UROSHEATH TYPE, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ec6517f-e1a8-4eb7-9b80-7a42d53763ff
Public Version Date: February 03, 2025
Public Version Number: 3
DI Record Publish Date: September 22, 2020