AccessGUDID - DEVICE: Dover (10192253058451)

GUDID

Device Identifier (DI) Information

Brand Name: Dover
Version or Model: 8887660127
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8887660127
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10192253058451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: RED RUBBER ROBINSON URETHRAL CATHETER, RADIOPAQUE E, SMOOTH ROUNDED TIP, 12 FR (4.0 MM)

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):	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?
46626	Intermittent urethral drainage catheter, antimicrobial	A flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal; it is also coated with an antibiotic or antimicrobial agent to help prevent infection of the urinary tract. This is a reusable device on the same patient for a limited period of time.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBM	CATHETER, URETHRAL

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: 2727df51-107c-4c94-936e-ea0ba37d2275
Public Version Date: January 31, 2025
Public Version Number: 1
DI Record Publish Date: January 23, 2025