U-Motion II PS+ Cup, multi-hole 1306-3556

GUDID 04711605568531

U-Motion II PS+ Cup, multi-hole, Ø56mm

UNITED ORTHOPEDIC CORP.

Ceramic-on-polyethylene total hip prosthesis

• Primary Device ID: 04711605568531
• NIH Device Record Key: 55cda197-23c0-4b23-9013-886ba285e39b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Motion II PS+ Cup, multi-hole
• Version Model Number: 1306-3556
• Catalog Number: 1306-3556
• 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	04711605568531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132455

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: 2018-08-07
• Device Publish Date: 2015-10-24

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• 04711605568531: U-Motion II PS+ Cup, multi-hole, Ø56mm
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• 04711605568494: U-Motion II PS+ Cup, multi-hole, Ø48mm
• 04711605568487: U-Motion II PS+ Cup, multi-hole, Ø46mm
• 04711605568470: U-Motion II PS+ Cup, multi-hole, Ø44mm