U1 Hip System, Hip Stem, With Collar Porous Coated 1101-1040

GUDID 04712602340045

UNITED U1 Hip stem, porous coated, #4

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712602340045
• NIH Device Record Key: b829c82b-d975-4e7b-983f-897781501b39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Hip System, Hip Stem, With Collar Porous Coated
• Version Model Number: 1101-1040
• Catalog Number: 1101-1040
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602340045 [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, Hip Stem, With Collar Porous Coated]

• 04712602340083: UNITED U1 Hip stem, porous coated, #7
• 04712602340076: UNITED U1 Hip stem, porous coated, #6
• 04712602340069: UNITED U1 Hip stem, porous coated, #5
• 04712602340052: UNITED U1 Hip stem, porous coated, #4.5
• 04712602340045: UNITED U1 Hip stem, porous coated, #4
• 04712602340038: UNITED U1 Hip stem, porous coated, #3
• 04712602340021: UNITED U1 Hip stem, porous coated, #2.5