DEVICE: UTF Hip Stem (04711605585224)

Device Identifier (DI) Information

UTF Hip Stem
9106-6707
In Commercial Distribution
9106-6707
UNITED ORTHOPEDIC CORP.
04711605585224
GS1

1
656700556 *Terms of Use
UTF Broach, female, reduced, ML 0mm, #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
LZP Aid, Surgical, Viscoelastic
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K123550 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
No Device Sizes
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Device Record Status

dca3a765-d52c-485c-b3c1-73c6a6468ae7
July 02, 2019
7
May 26, 2017
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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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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