UCP Stem, cemented 1107-3010

GUDID 04711605569101

UCP Stem, cemented, #1

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04711605569101
• NIH Device Record Key: 77533af8-9b9b-4634-b53f-f6eaba07f2ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCP Stem, cemented
• Version Model Number: 1107-3010
• Catalog Number: 1107-3010
• 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	04711605569101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152530

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-08
• Device Publish Date: 2016-03-31

On-Brand Devices [UCP Stem, cemented]

• 04711605569149: UCP Stem, cemented, #5
• 04711605569132: UCP Stem, cemented, #4
• 04711605569125: UCP Stem, cemented, #3
• 04711605569118: UCP Stem, cemented, #2
• 04711605569101: UCP Stem, cemented, #1
• 04711605569095: UCP Stem, cemented, #0