Bipolar II™ 1503-4256

GUDID 04719872178859

U2 Bipolar trial, φ56mm, ID 32mm

UNITED ORTHOPEDIC CORP.

Acetabulum prosthesis trial, reusable

• Primary Device ID: 04719872178859
• NIH Device Record Key: 1bc58f4b-c486-4626-b38d-8f8bb1b82ad6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar II™
• Version Model Number: 1503-4256
• Catalog Number: 1503-4256
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	04719872178859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110245

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04719872178859]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-07-13

On-Brand Devices [Bipolar II™]

• 04719872179269: U2 Bipolar Case
• 04719872179207: Head remover, φ32mm
• 04719872178859: U2 Bipolar trial, φ56mm, ID 32mm
• 04719872178842: U2 Bipolar trial, φ55mm, ID 32mm
• 04719872178835: U2 Bipolar trial, φ54mm, ID 32mm
• 04719872178828: U2 Bipolar trial, φ53mm, ID 32mm
• 04719872178811: U2 Bipolar trial, φ52mm, ID 32mm
• 04719872178804: U2 Bipolar trial, φ51mm, ID 32mm
• 04719872178798: U2 Bipolar trial, φ50mm, ID 32mm
• 04719872177883: U2 Bipolar case
• 04719872173786: U2 Bipolar Case
• 04719872173779: Size plate,Bipolar II
• 04719872173762: Size plate, Bipolar II
• 04719872173601: Bipolar trial handle
• 04719872173526: Head remover, φ28mm
• 04719872173519: Head remover, φ26mm
• 04719872173502: Head remover, Ø22mm
• 04719872168744: U2 Bipolar trial, Ø42mm, ID 22mm
• 04719872168737: U2 Bipolar trial, Ø41mm, ID 22mm
• 04719872168720: U2 Bipolar trial, Ø40mm, ID 22mm
• 04719872168713: U2 Bipolar trial, Ø39mm, ID 22mm
• 04719872168706: U2 Bipolar trial, Ø38mm, ID 22mm
• 04719872168690: U2 Bipolar trial, φ56mm, ID 28mm
• 04719872168683: U2 Bipolar trial, φ55mm, ID 28mm
• 04719872168676: U2 Bipolar trial, φ54mm, ID 28mm
• 04719872168669: U2 Bipolar trial, φ53mm, ID 28mm
• 04719872168652: U2 Bipolar trial, φ52mm, ID 28mm
• 04719872168645: U2 Bipolar trial, φ51mm, ID 28mm
• 04719872168638: U2 Bipolar trial, φ50mm, ID 28mm
• 04719872168621: U2 Bipolar trial, φ49mm, ID 28mm
• 04719872168614: U2 Bipolar trial, φ48mm, ID 28mm
• 04719872168607: U2 Bipolar trial, φ47mm, ID 28mm
• 04719872168591: U2 Bipolar trial, φ46mm, ID 28mm
• 04719872168584: U2 Bipolar trial, φ45mm, ID 28mm
• 04719872168577: U2 Bipolar trial, φ44mm, ID 28mm
• 04719872168560: U2 Bipolar trial, φ43mm, ID 28mm
• 04719872168553: U2 Bipolar trial, φ42mm, ID 26mm
• 04719872162261: U2 Bipolar trial, φ41mm, ID 26mm