U2 Bipolar Implant 1503-3342

GUDID 04711605579186

U2 Bipolar Implant, 22mm I.D., 42mm O.D.

UNITED ORTHOPEDIC CORP.

Femoral head bipolar component Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 04711605579186
• NIH Device Record Key: e44fa2e1-1174-4a2f-bfa4-d511e2b021ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Bipolar Implant
• Version Model Number: 1503-3342
• Catalog Number: 1503-3342
• 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: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605579186 [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