U2 Acetabular Components, Ti Porous Coated 1303-5464

GUDID 04712602342537

U2 Acetabular cup, Ti porous coated, Ø64mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712602342537
• NIH Device Record Key: b51aad80-eec1-4017-a4e0-025cd4e804dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Acetabular Components, Ti Porous Coated
• Version Model Number: 1303-5464
• Catalog Number: 1303-5464
• 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: 64 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602342537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111546

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: 2018-08-03
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 Acetabular Components, Ti Porous Coated]

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• 04712602342537: U2 Acetabular cup, Ti porous coated, Ø64mm
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• 04712602342452: U2 Acetabular cup, Ti porous coated, Ø48mm
• 04712602342445: U2 Acetabular cup, Ti porous coated, Ø46mm
• 04712602342438: U2 Acetabular cup, Ti porous coated, Ø44mm