DEVICE: DELTA Multihole TT Pro (08033390151207)

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Device Record History
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Device Identifier (DI) Information
DELTA Multihole TT Pro
5554.14.523
In Commercial Distribution
5554.14.523
LIMACORPORATE SPA
08033390151207
GS1

1
432066322 *Terms of Use
Acetabular Cup Dia. 52 mm (Liner #MEDIUM+)
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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?
60516 Metallic acetabulum prosthesis
A sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of metal [e.g., stainless steel, titanium (Ti)]. Devices designed to assist implantation/fixation (e.g., screws, surgical guides, trial prosthesis, anatomical models) may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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
Device Size Text, specify: Dia. 52 mm (Liner #MEDIUM+)
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Device Record Status
53717fbc-5b93-438a-b881-98ae91de8ef5
January 08, 2024
2
November 09, 2019
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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