UTF Hip Stem 9106-6016-RA

GUDID 04719872167334

UTF Broach, #16.5

UNITED ORTHOPEDIC CORP.

Orthopaedic broach

• Primary Device ID: 04719872167334
• NIH Device Record Key: 565a1d8a-7634-4135-9e18-f29f9fc05e04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTF Hip Stem
• Version Model Number: 9106-6016-RA
• Catalog Number: 9106-6016-RA
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872167334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110245

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04719872167334]

Moist Heat or Steam Sterilization

[04719872167334]

Moist Heat or Steam Sterilization

[04719872167334]

Moist Heat or Steam Sterilization

[04719872167334]

Moist Heat or Steam Sterilization

[04719872167334]

Moist Heat or Steam Sterilization

[04719872167334]

Moist Heat or Steam Sterilization

[04719872167334]

Moist Heat or Steam Sterilization

[04719872167334]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-04
• Device Publish Date: 2022-06-24

On-Brand Devices [UTF Hip Stem]

• 04719872177814: UTF Broach, reduced, ML 0mm case
• 04719872177807: UTF Stem, reduced case #2
• 04719872177791: UTF Stem, reduced case #1
• 04719872177784: UTF Stem, reduced, case #1
• 04719872172758: UTF Stem, reduced, case #2
• 04719872172741: UTF Stem, reduced, case #1
• 04719872172734: UTF Stem, reduced case #1
• 04719872172710: UTF Stem, case #2
• 04719872172697: UTF Stem, case #1
• 04719872171232: UTF Neck trial, reduced, high offset, #0
• 04719872171188: UTF Neck trial, reduced, standard, #0~#00
• 04719872167594: UTF Broach, reduced, ML 0mm, #00
• 04719872167587: UTF Broach, reduced, #00
• 04719872167570: UTF Broach, reduced, ML 0mm, #13
• 04719872167549: UTF Broach, reduced, ML 0mm, #10
• 04719872167518: UTF Broach, reduced, ML 0mm, #8
• 04719872167495: UTF Broach, reduced, ML 0mm, #6
• 04719872167471: UTF Broach, reduced, ML 0mm, #5
• 04719872167457: UTF Broach, reduced, ML 0mm, #4
• 04719872167426: UTF Broach, reduced, ML 0mm, #2
• 04719872167402: UTF Broach, reduced, ML 0mm, #1
• 04719872167396: UTF Broach, reduced, #0
• 04719872157014: UTF Broach, reduced, ML 0mm, #12
• 04719872156994: UTF Broach, reduced, ML 0mm, #11
• 04719872156987: UTF Broach, reduced, ML 0mm, #9
• 04719872156970: UTF Broach, reduced, ML 0mm, #7
• 04719872156956: UTF Broach, reduced, ML 0mm, #3
• 04719872156932: UTF Broach, reduced, ML 0mm, #0
• 04719872156925: UTF Broach, #22
• 04719872156918: UTF Broach, #19
• 04719872156901: UTF Broach, #14.5
• 04719872156895: UTF Broach, #10
• 04719872156888: UTF Broach, #7.5
• 04711605584517: UTF Stem, reduced, case #1
• 04711605582445: Straight stem impactor
• 04711605582049: Curved stem impactor
• 04711605585330: Hip stem basic case
• 04711605585323: UTF-r case
• 04711605585316: Femoral cutting chisel, female
• 04711605585293: UTF Broach, female, reduced, ML 0mm, #14
• 04711605585286: UTF Broach, female, reduced, ML 0mm, #13
• 04711605585279: UTF Broach, female, reduced, ML 0mm, #12
• 04711605585262: UTF Broach, female, reduced, ML 0mm, #11
• 04711605585255: UTF Broach, female, reduced, ML 0mm, #10
• 04711605585248: UTF Broach, female, reduced, ML 0mm, #9
• 04711605585231: UTF Broach, female, reduced, ML 0mm, #8
• 04711605585224: UTF Broach, female, reduced, ML 0mm, #7
• 04711605585217: UTF Broach, female, reduced, ML 0mm, #6
• 04711605585200: UTF Broach, female, reduced, ML 0mm, #5
• 04711605585194: UTF Broach, female, reduced, ML 0mm, #4