UCP™ Stem 9107-6421

GUDID 04719872167631

UCP Stem broach, #2, 180mm

UNITED ORTHOPEDIC CORP.

Orthopaedic broach

• Primary Device ID: 04719872167631
• NIH Device Record Key: 90f66db1-71d1-47d0-a2b8-b89482128929
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCP™ Stem
• Version Model Number: 9107-6421
• Catalog Number: 9107-6421
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• Device Count: 1
• DM Exempt: true
• 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: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872167631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152530

FDA Product Code

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

Sterilization

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

[04719872167631]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-15

On-Brand Devices [UCP™ Stem]

• 04719872177845: UCP Stem case #2
• 04719872177838: UCP Stem case #1
• 04719872177821: Non-Ratcheting handle
• 04719872172840: UCP Canal sizer/reamer, 18mm
• 04719872172833: UCP Canal sizer/reamer, 16mm
• 04719872172826: UCP Canal sizer/reamer, 14mm
• 04719872172819: UCP Canal sizer/reamer, 12mm
• 04719872172802: UCP Canal sizer/reamer, 10mm
• 04719872172796: UCP Locator pin
• 04719872172789: UCP Start reamer
• 04719872172772: UCP Neck resection guide
• 04719872172765: UCP Cement restrictor inserter
• 04719872167648: UCP Stem broach, #3, 180mm
• 04719872167631: UCP Stem broach, #2, 180mm
• 04719872167624: UCP Stem broach, #4
• 04719872167617: UCP Stem broach, #2
• 04719872167600: UCP Stem broach, #1
• 04719872159131: UCP Stem trial, long stem, #3, 230mm
• 04719872159124: UCP Stem trial, long stem, #3, 210mm
• 04719872157069: UCP Stem broach, #5
• 04719872157052: UCP Stem broach, #3
• 04719872157045: UCP Stem broach, #0