DEVICE: U2 Acetabular Components, XPE Cup Liner (04712771483703)

Device Identifier (DI) Information

U2 Acetabular Components, XPE Cup Liner
1403-1056
In Commercial Distribution
1403-1056
UNITED ORTHOPEDIC CORP.
04712771483703
GS1

1
656700556 *Terms of Use
XPE Cup Liner, ID 28 mm, 10°× 56mm
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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. 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?
33181 Metal-on-polyethylene total hip prosthesis
A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111546 000
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
Angle: 10 degree
Lumen/Inner Diameter: 28 Millimeter
Outer Diameter: 56 Millimeter
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Device Record Status

4f2a8c8f-6e38-4694-8668-a782c2c2019e
August 06, 2018
4
October 24, 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
Yes
No
No CLOSE

Customer Contact

[?]
+886229294567
service@uoc.com.tw
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