U2 Hip Stem, HA/Ti Plasma Spray 1104-1045

GUDID 04712602340304

UNITED U2 Hip stem, HA/Ti plasma spray, #4, Ø12

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712602340304
• NIH Device Record Key: 6ff0a76b-07f8-4755-a386-743043426235
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Hip Stem, HA/Ti Plasma Spray
• Version Model Number: 1104-1045
• Catalog Number: 1104-1045
• 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	04712602340304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003237

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 Hip Stem, HA/Ti Plasma Spray]

• 04712602340359: UNITED U2 Hip stem, HA/Ti plasma spray, #7, Ø15
• 04712602340342: UNITED U2 Hip stem, HA/Ti plasma spray, #6, Ø14
• 04712602340335: UNITED U2 Hip stem, HA/Ti plasma spray, #6, Ø13
• 04712602340328: UNITED U2 Hip stem, HA/Ti plasma spray, #5, Ø13
• 04712602340311: UNITED U2 Hip stem, HA/Ti plasma spray, #5, Ø12
• 04712602340304: UNITED U2 Hip stem, HA/Ti plasma spray, #4, Ø12
• 04712602340298: UNITED U2 Hip stem, HA/Ti plasma spray, #4, Ø11
• 04712602340281: UNITED U2 Hip stem, HA/Ti plasma spray, #3, Ø12
• 04712602340274: UNITED U2 Hip stem, HA/Ti plasma spray, #3, Ø11
• 04712602340267: UNITED U2 Hip stem, HA/Ti plasma spray, #3, Ø10
• 04712602340250: UNITED U2 Hip stem, HA/Ti plasma spray, #2, Ø11
• 04712602340243: UNITED U2 Hip stem, HA/Ti plasma spray, #2, Ø10
• 04712602340236: UNITED U2 Hip stem, HA/Ti plasma spray, #1, Ø9