DEVICE: KindKlamp (00653599000007)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
43437f0a-e933-46cd-a664-abec6762a730
April 11, 2024
3
January 22, 2020
April 11, 2024
3
January 22, 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 |
---|---|
HIBCC | M456200030 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-864-6755
CustomerCare@BioDermInc.com
CustomerCare@BioDermInc.com