United Hip System 1110-7001

GUDID 04711605583732

Conformity stem, cemented, high offset, #8

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04711605583732
• NIH Device Record Key: d9c0b516-66e0-47b4-a29f-d3fa09ba9ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: United Hip System
• Version Model Number: 1110-7208
• Catalog Number: 1110-7001
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04711605583732 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191056

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: 2020-03-05
• Device Publish Date: 2020-02-26

On-Brand Devices [United Hip System]

• 04711605583565: Conformity stem, cemented, #1
• 04711605583756: Conformity stem, cemented, high offset, #10
• 04711605583749: Conformity stem, cemented, high offset, #9
• 04711605583732: Conformity stem, cemented, high offset, #8
• 04711605583725: Conformity stem, cemented, high offset, #7
• 04711605583718: Conformity stem, cemented, high offset, #6
• 04711605583701: Conformity stem, cemented, high offset, #5
• 04711605583695: Conformity stem, cemented, high offset, #4
• 04711605583688: Conformity stem, cemented, high offset, #3
• 04711605583671: Conformity stem, cemented, high offset, #2
• 04711605583664: Conformity stem, cemented, high offset, #1
• 04711605583657: Conformity stem, cemented, #10
• 04711605583640: Conformity stem, cemented, #9
• 04711605583633: Conformity stem, cemented, #8
• 04711605583626: Conformity stem, cemented, #7
• 04711605583619: Conformity stem, cemented, #6
• 04711605583602: Conformity stem, cemented, #5
• 04711605583596: Conformity stem, cemented, #4
• 04711605583589: Conformity stem, cemented, #3
• 04711605583572: Conformity stem, cemented, #2
• 04719872140924: U-Motion II PS+ Cup, Multi-Hole, OD54mm, ID40mm
• 04719872140917: U-Motion II PS+ Cup, Multi-Hole, OD48mm, ID36mm
• 04719872140887: U-Motion II PS+ Cup, No-Hole, OD54mm, ID40mm
• 04719872140870: U-Motion II PS+ Cup, No-Hole, OD48mm, ID36mm
• 04719872140849: U-Motion II PS+ Cup, Cluster-Hole, OD54mm, ID40mm
• 04719872140832: U-Motion II PS+ Cup, Cluster-Hole, OD48mm, ID36mm
• 04719872140740: U-Motion II XPE Cup Liner, 20 Degrees, ID40mm, OD54mm
• 04719872140733: U-Motion II XPE Cup Liner, 0 Degree, ID40mm, OD54mm
• 04719872140726: U-Motion II XPE Cup Liner, 0 Degree, ID36mm, OD48mm
• 04719872140719: U-Motion II PS Cup, No-Hole, OD54mm, ID40mm
• 04719872140702: U-Motion II PS Cup, No-Hole, OD48mm, ID36mm
• 04719872140672: U-Motion II PS Cup, Multi-Hole, OD54mm, ID40mm
• 04719872140665: U-Motion II PS Cup, Multi-Hole, OD48mm, ID36mm
• 04719872140634: U-Motion II PS Cup, Cluster-Hole, OD54mm, ID40mm
• 04719872140627: U-Motion II PS Cup, Cluster-Hole, OD48mm, ID36mm
• 04719872140115: U-Motion II XPE Cup Liner, 20 Degrees, 36mm ID, 48mm OD