DEVICE: Malem (05060049630199)

Device Identifier (DI) Information

Malem
PC9
In Commercial Distribution

MALEM MEDICAL LIMITED
05060049630199
GS1

1
291490076 *Terms of Use
Queen's Square Bladder Stimulator (PC9)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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No
No

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?
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).
Active false
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FDA Product Code

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Product Code Product Code Name
ISA Massager, Therapeutic, Electric
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c1dc89db-cae3-4b8a-9d01-c8d229255f83
March 29, 2018
2
October 06, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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