DEVICE: C2 REVISION Hip (08033390141871)

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Device Record History
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Device Identifier (DI) Information
C2 REVISION Hip
9045.14.080
In Commercial Distribution
9045.14.080
LIMACORPORATE SPA
08033390141871
GS1

1
432066322 *Terms of Use
C2 REVISION Hip - Broach # 6
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36167 Orthopaedic broach
A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K170473 000
No CLOSE

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
Device Size Text, specify: # 6
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Device Record Status
782c1501-7556-4b98-8f7f-d0dabbeda18b
July 06, 2018
2
March 13, 2018
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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

[?]
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

[?]
No Customer Contact currently defined
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