DEVICE: Chisel handle (07640187910513)

Device Identifier (DI) Information

Chisel handle
T14584
In Commercial Distribution
T14584
MPS Micro Precision Systems AG
07640187910513
GS1

1
482204059 *Terms of Use
A hand-held instrument used to maintain and hold chisel blade of different designs (straight, curved, offset, etc.). The exchange of the chisel blades occur simply by tightening and loosening the screw by use of the Allen key. In case the chisel blade remains stocked, the slap hammer can be screwed at the handle extremity. This is a reusable device.
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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© 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?
62895 Orthopaedic osteotome handle
A hand-held component of an orthopaedic osteotome intended to be attached to an interchangeable blade (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. The operator holds this part of the instrument and manually imparts a force to it using a surgical mallet or hammer; it is made of metal and/or polymer materials. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FZO Chisel, Surgical, Manual
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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

045c9c38-2299-425d-9c35-b94b833d79b1
November 18, 2022
2
August 25, 2020
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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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
999-999-9999
customers@mpsprecimed.com
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