AccessGUDID - DEVICE: Uro-Con® "High-Quality" Latex Sheaths, Medium 30mm (Box of 100) (00792293503305)

GUDID

Device Identifier (DI) Information

Brand Name: Uro-Con® "High-Quality" Latex Sheaths, Medium 30mm (Box of 100)
Version or Model: 500330
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500330
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293503305
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: SHEATH, MALE, EXTERNAL, CATHETER, LATEX, HIGH-QUALITY, DISPOSABLE, MEDIUM 30MM BOX of 100 These latex sheaths are used in conjunction with Uro-Con® Catheter Inserts and pliable white-rubber tubing to construct Uro-Con® “Texas-Style” male external catheters

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
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
Device Size Text, specify: Medium
Weight: 0.38 Pound
Outer Diameter: 30 Millimeter

Device Record Status

Public Device Record Key: 98ed4d3d-ad09-4eee-bd91-ff7c67583525
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: May 30, 2018