DEVICE: BATTERY PACK, KLS-SD-2000, SINGLE (00856482008122)

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Device Record History
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Device Identifier (DI) Information
BATTERY PACK, KLS-SD-2000, SINGLE
KLS-BP2-001
In Commercial Distribution

PRO-DEX, INC.
00856482008122
GS1

1
849370358 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
48058 Disposable battery pack
A group of battery cells (e.g., lithium ion cells) held within a container that is sterile used to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. This device is typically designed to power cordless surgical power tools (e.g., a non-rechargeable battery-powered surgical drilling system handpiece) and is non-rechargeable. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
GEY Motor, Surgical Instrument, Ac-Powered
GXL Screwdriver, Skullplate
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
5ddff79b-a6a9-4c8e-9ea6-68b5b4cecc2d
December 19, 2024
2
March 29, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10856482008129 40 00856482008122 In Commercial Distribution
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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