DEVICE: Malem (05060049630144)
Device Identifier (DI) Information
Malem
PC9S
In Commercial Distribution
MALEM MEDICAL LIMITED
PC9S
In Commercial Distribution
MALEM MEDICAL LIMITED
Queen's Square Bladder Stimulator - Selectable (PC9S)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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62355 | Bladder-emptying vibratory stimulator |
A battery-powered, hand-held device intended to be used in the home or healthcare facility by a patient to help initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation. It is an electronic unit with a handle and massaging head held against the skin surface that is typically used by patients who have problems voiding due to disorders of neuromuscular origin (e.g., multiple sclerosis).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ISA | Massager, Therapeutic, Electric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a426e6ac-56d5-46da-b4b8-7c1f576f45d7
March 29, 2018
2
October 06, 2016
March 29, 2018
2
October 06, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
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
[?]
No Customer Contact currently defined