UTS Stem, Ti plasma spray, high offset 1106-5201

GUDID 04719872156345

UTS Stem, Ti plasma spray, high offset, #1

UNITED ORTHOPEDIC CORP.

Revision coated hip femur prosthesis

• Primary Device ID: 04719872156345
• NIH Device Record Key: a589ab05-82fa-4629-bb71-7838bc28246e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTS Stem, Ti plasma spray, high offset
• Version Model Number: 1106-5201
• Catalog Number: 1106-5201
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872156345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172251

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-10
• Device Publish Date: 2018-08-08

On-Brand Devices [UTS Stem, Ti plasma spray, high offset]

• 04719872156475: UTS Stem, Ti plasma spray, high offset, #14
• 04719872156468: UTS Stem, Ti plasma spray, high offset, #13
• 04719872156451: UTS Stem, Ti plasma spray, high offset, #12
• 04719872156444: UTS Stem, Ti plasma spray, high offset, #11
• 04719872156437: UTS Stem, Ti plasma spray, high offset, #10
• 04719872156420: UTS Stem, Ti plasma spray, high offset, #9
• 04719872156413: UTS Stem, Ti plasma spray, high offset, #8
• 04719872156406: UTS Stem, Ti plasma spray, high offset, #7
• 04719872156390: UTS Stem, Ti plasma spray, high offset, #6
• 04719872156383: UTS Stem, Ti plasma spray, high offset, #5
• 04719872156376: UTS Stem, Ti plasma spray, high offset, #4
• 04719872156369: UTS Stem, Ti plasma spray, high offset, #3
• 04719872156352: UTS Stem, Ti plasma spray, high offset, #2
• 04719872156345: UTS Stem, Ti plasma spray, high offset, #1