DEVICE: MasterSL Hip (08033390197731)

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Device Record History
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Device Identifier (DI) Information
MasterSL Hip
9035.15.470
In Commercial Distribution
9035.15.470
LIMACORPORATE SPA
08033390197731
GS1

1
432066322 *Terms of Use
Broach #7
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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
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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 [?]
K140975 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
Device Size Text, specify: #7
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Device Record Status
bebc898b-f77f-488c-bcff-13fb2016827f
March 26, 2021
1
March 18, 2021
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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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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