DEVICE: Delta Dual Mobility System (08033390086332)

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Device Record History
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Device Identifier (DI) Information
Delta Dual Mobility System
5885.09.040
In Commercial Distribution
5885.09.040
LIMACORPORATE SPA
08033390086332
GS1

1
432066322 *Terms of Use
Liner #M for Mobile Liner Dia. 40 mm
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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?
48055 Ceramic acetabular liner
A sterile implantable inner component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of ceramic material (e. g alumina).
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous 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 [?]
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: #M Dia. 40 mm
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Device Record Status
3e6a60f5-f72e-44fd-a3d5-f1c4fd0087b7
October 14, 2024
2
June 25, 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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