AccessGUDID - DEVICE: Cure Catheter® Closed System (00815947020840)

GUDID

Device Identifier (DI) Information

Brand Name: Cure Catheter® Closed System
Version or Model: CSL12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 00815947020840
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: Closed System Complete Urinary Catheterization System with Catheter Control Feature, Straight Tip

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):	Yes
Over the Counter (OTC):	No
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?
45605	Single-administration urethral catheterization kit, single-use	A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Catheter Gauge: 12 French

Device Record Status

Public Device Record Key: 6b7e32a8-a35d-45ff-8cef-1c8cb885d172
Public Version Date: February 02, 2022
Public Version Number: 4
DI Record Publish Date: December 31, 2017