DEVICE: LEGION (03596010549983)

Device Identifier (DI) Information

LEGION
71434348
In Commercial Distribution
71434348
Smith & Nephew, Inc.
03596010549983
GS1

1
045483575 *Terms of Use
LEGION TIBIAL FIN PUNCH SIZE 7-8
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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. 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?
64337 Bone-coring punch, reusable
A hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HRY PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121393 000
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Sterilization

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

f55e8aa7-a4da-4636-ba72-1e87bc7286d6
September 07, 2023
6
August 30, 2015
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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
No Package DIs found
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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
No
No
No CLOSE

Customer Contact

[?]
+1(800)238-7538
GUDID@SMITH-NEPHEW.COM
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