U2 Bipolar Implant 1503-3338

GUDID 04711605579148

U2 Bipolar Implant, 22mm I.D., 38mm O.D.

UNITED ORTHOPEDIC CORP.

Femoral head bipolar component

• Primary Device ID: 04711605579148
• NIH Device Record Key: 94fca3f3-d925-4e9d-be7b-32bff8ae37bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Bipolar Implant
• Version Model Number: 1503-3338
• Catalog Number: 1503-3338
• 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
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605579148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152439

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 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: 2018-08-08
• Device Publish Date: 2016-06-06

On-Brand Devices [U2 Bipolar Implant]

• 04719872177890: U2 Bipolar case
• 04719872173793: U2 Bipolar case
• 04711605581936: U2 Bipolar trial, ID22mm, OD42mm
• 04711605581929: U2 Bipolar trial, ID22mm, OD41mm
• 04711605581912: U2 Bipolar trial, ID22mm, OD40mm
• 04711605581905: U2 Bipolar trial, ID22mm, OD39mm
• 04711605581899: U2 Bipolar trial, ID22mm, OD38mm
• 04711605579186: U2 Bipolar Implant, 22mm I.D., 42mm O.D.
• 04711605579179: U2 Bipolar Implant, 22mm I.D., 41mm O.D.
• 04711605579162: U2 Bipolar Implant, 22mm I.D., 40mm O.D.
• 04711605579155: U2 Bipolar Implant, 22mm I.D., 39mm O.D.
• 04711605579148: U2 Bipolar Implant, 22mm I.D., 38mm O.D.
• 04719872141112: Bipolar trial handle
• 04719872140443: U2 Bipolar trial, Ø42mm, ID22mm
• 04719872140436: U2 Bipolar trial, Ø41mm, ID22mm
• 04719872140429: U2 Bipolar trial, Ø40mm, ID22mm
• 04719872140412: U2 Bipolar trial, Ø39mm, ID22mm
• 04719872140405: U2 Bipolar trial, Ø38mm, ID22mm
• 04719872140399: U2 Bipolar trial, Ø56mm, ID28mm
• 04719872140382: U2 Bipolar trial, Ø55mm, ID28mm
• 04719872140375: U2 Bipolar trial, Ø54mm, ID28mm
• 04719872140368: U2 Bipolar trial, Ø53mm, ID28mm
• 04719872140351: U2 Bipolar trial, Ø52mm, ID28mm
• 04719872140344: U2 Bipolar trial, Ø51mm, ID28mm
• 04719872140337: U2 Bipolar trial, Ø50mm, ID28mm
• 04719872140320: U2 Bipolar trial, Ø49mm, ID28mm
• 04719872140313: U2 Bipolar trial, Ø48mm, ID28mm
• 04719872140306: U2 Bipolar trial, Ø47mm, ID28mm
• 04719872140290: U2 Bipolar trial, Ø46mm, ID28mm
• 04719872140283: U2 Bipolar trial, Ø45mm, ID28mm
• 04719872140276: U2 Bipolar trial, Ø44mm, ID28mm
• 04719872140269: U2 Bipolar trial, Ø43mm, ID28mm
• 04719872140252: U2 Bipolar trial, Ø42mm, ID26mm
• 04719872140245: U2 Bipolar trial, Ø41mm, ID26mm
• 04719886893595: U2 Bipolar trial, Ø60mm, ID28mm
• 04719886893588: U2 Bipolar trial, Ø58mm, ID28mm