DEVICE: emPOWER (B155EM30)

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Device Record History
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Device Identifier (DI) Information
emPOWER
em3
In Commercial Distribution

BIONX MEDICAL TECHNOLOGIES, INC.
B155EM30
HIBCC

1
788290471 *Terms of Use
emPOWER Battery Charger
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
External device battery charger An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to an external parent device (i.e., nonimplantable device) or external battery pack, to recharge it for operation.
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FDA Product Code

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Product Code Product Code Name
ISW Assembly, Knee/Shank/Ankle/Foot, External
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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
abdf1a33-094c-443a-8e20-fb6f25d7e40b
March 29, 2018
2
October 27, 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
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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