U1 Hip System, Acetabular Cup Liner 1401-1060

GUDID 04712602343077

U1 Acetabular cup liner assembly, 20°hooded,60mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712602343077
• NIH Device Record Key: 1bd91a16-9d99-45c7-ac5e-23e365f03805
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Hip System, Acetabular Cup Liner
• Version Model Number: 1401-1060
• Catalog Number: 1401-1060
• 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

• Outer Diameter: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602343077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994078

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2018-08-02
• Device Publish Date: 2015-10-24

On-Brand Devices [U1 Hip System, Acetabular Cup Liner]

• 04712602343084: U1 Acetabular cup liner assembly, 20°hooded,62mm
• 04712602343077: U1 Acetabular cup liner assembly, 20°hooded,60mm
• 04712602343060: U1 Acetabular cup liner assembly, 20°hooded,58mm
• 04712602343053: U1 Acetabular cup liner assembly, 20°hooded,56mm
• 04712602343046: U1 Acetabular cup liner assembly, 20°hooded,54mm
• 04712602343039: U1 Acetabular cup liner assembly, 20°hooded,52mm
• 04712602343022: U1 Acetabular cup liner assembly, 20°hooded,50mm
• 04712602343015: U1 Acetabular cup liner assembly, 20°hooded,48mm
• 04712602343008: U1 Acetabular cup liner assembly, 20°hooded,46mm
• 04712602342995: U1 Acetabular cup liner assembly, 20°hooded,44mm