U2 Hip Stem, Ti Porous Coated, Matrix 1104-3212

GUDID 04712771495751

Hip stem, Ti porous coated, matrix, #1, φ9

UNITED ORTHOPEDIC CORP.

Revision coated hip femur prosthesis

• Primary Device ID: 04712771495751
• NIH Device Record Key: b06a7d50-b16f-4354-b12e-d727e2746637
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Hip Stem, Ti Porous Coated, Matrix
• Version Model Number: 1104-3212
• Catalog Number: 1104-3212
• 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	04712771495751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151316

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 Hip Stem, Ti Porous Coated, Matrix]

• 04712771495874: Hip stem, Ti porous coated, matrix, #7, φ15
• 04712771495867: Hip stem, Ti porous coated, matrix, #6, φ14
• 04712771495850: Hip stem, Ti porous coated, matrix, #6, φ13
• 04712771495843: Hip stem, Ti porous coated, matrix, #5, φ13
• 04712771495836: Hip stem, Ti porous coated, matrix, #5, φ12
• 04712771495829: Hip stem, Ti porous coated, matrix, #4, φ12
• 04712771495812: Hip stem, Ti porous coated, matrix, #4, φ11
• 04712771495805: Hip stem, Ti porous coated, matrix, #3, φ12
• 04712771495799: Hip stem, Ti porous coated, matrix, #3, φ11
• 04712771495782: Hip stem, Ti porous coated, matrix, #3, φ10
• 04712771495775: Hip stem, Ti porous coated, matrix, #2, φ11
• 04712771495768: Hip stem, Ti porous coated, matrix, #2, φ10
• 04712771495751: Hip stem, Ti porous coated, matrix, #1, φ9