AccessGUDID - DEVICE: Incontinence Clamp (00801741072765)

GUDID

Device Identifier (DI) Information

Brand Name: Incontinence Clamp
Version or Model: 004054
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 004054
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741072765
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Cunningham Incontinence Clamp, Large

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:	No
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?
42797	Incontinence penis clamp, reusable	A male urinary incontinence device designed to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder. It is typically made of plastic materials and is designed as an adjustable, two-hinged, self-retaining lever clamp with foam rubber inserts; the user can typically adjust the tension to suit their penis size and needs. It is removed by the user when voiding and then reapplied. The device is washed/disinfected at regular intervals to maintain hygiene. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHA	CLAMP, PENILE

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: 8f151c75-c5e1-47db-87e2-b90faf060bfa
Public Version Date: September 14, 2020
Public Version Number: 1
DI Record Publish Date: September 04, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)526-4455
Email: medical.services@crbard.com

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