U2 Acetabular Cup, CCM Porous Coated 1303-5054

GUDID 04712771506716

U2 Acetabular cup, CCM porous coated, Ø54mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712771506716
• NIH Device Record Key: 121ce431-33f1-41f9-9918-8935db55ec64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Acetabular Cup, CCM Porous Coated
• Version Model Number: 1303-5054
• Catalog Number: 1303-5054
• 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: 54 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712771506716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022520

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 [U2 Acetabular Cup, CCM Porous Coated]

• 04712771506754: 1303-5062
• 04712771506747: U2 Acetabular cup, CCM porous coated, Ø60mm
• 04712771506730: U2 Acetabular cup, CCM porous coated, Ø58mm
• 04712771506723: U2 Acetabular cup, CCM porous coated, Ø56mm
• 04712771506716: U2 Acetabular cup, CCM porous coated, Ø54mm
• 04712771506709: U2 Acetabular cup, CCM porous coated, Ø52mm
• 04712771506693: U2 Acetabular cup, CCM porous coated, Ø50mm
• 04712771506686: U2 Acetabular cup, CCM porous coated, Ø48mm
• 04712771506679: U2 Acetabular cup, CCM porous coated, Ø46mm
• 04712771506662: U2 Acetabular cup, CCM porous coated, Ø44mm