Ceramic Femoral Head BIOLOX® Forte 12/14S 1203-1028

GUDID 04712602341585

Ceramic Femoral Head, O.D.φ28mm, 12/14- S

UNITED ORTHOPEDIC CORP.

Ceramic-on-polyethylene total hip prosthesis

• Primary Device ID: 04712602341585
• NIH Device Record Key: 95290c48-92ba-4f3d-8071-38df85c994e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramic Femoral Head BIOLOX® Forte 12/14S
• Version Model Number: 1203-1028
• Catalog Number: 1203-1028
• 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: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602341585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103497

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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 [Ceramic Femoral Head BIOLOX® Forte 12/14S]

• 04712602341592: Ceramic Femoral Head, O.D.φ32mm, 12/14- S
• 04712602341585: Ceramic Femoral Head, O.D.φ28mm, 12/14- S