U2 Hip Stem 1104-2311

GUDID 04719872158844

Revision hip stem trial, curved, left,φ11×230mm

UNITED ORTHOPEDIC CORP.

Femoral stem prosthesis trial

• Primary Device ID: 04719872158844
• NIH Device Record Key: e70340d7-cde3-4381-81d7-afb4062ca326
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Hip Stem
• Version Model Number: 1104-2311
• Catalog Number: 1104-2311
• 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	04719872158844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062978

FDA Product Code

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

Sterilization

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

[04719872158844]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-06-21

On-Brand Devices [U2 Hip Stem]

• 04719872177753: U2 Hip case, #2
• 04719872177746: U2 Hip case, #1
• 04719872177739: U2 Stem case
• 04719872177722: U2 Hip basic case
• 04719872177715: U2 Revision hip trial case
• 04719872177708: U2 Revision hip stem case
• 04719872172390: Flexible reamer set case
• 04719872172383: U2 Revision hip trial case
• 04719872172376: U2 Revision hip stem case
• 04719872171119: Neck trial, Ø16.5, Ø18mm
• 04719872171102: Neck trial, φ16.5, φ18mm
• 04719872171096: Neck trial, Ø13, Ø14, Ø15mm
• 04719872171089: Neck trial, φ13, φ14, φ15mm
• 04719872171072: Neck trial, Ø11, Ø12mm
• 04719872171065: Neck trial, φ11, φ12mm
• 04719872170976: Neck trial, #0
• 04719872167136: Revision hip stem broach, Ø16.5mm
• 04719872167129: Revision hip stem broach, Ø14mm
• 04719872167112: Revision hip stem broach, Ø13mm
• 04719872167105: Revision hip stem broach, Ø12mm
• 04719872167099: U2 Broach, #7
• 04719872167082: U2 Broach, #7
• 04719872167068: U2 Broach, #6
• 04719872167051: U2 Broach, #6
• 04719872167037: U2 Broach, #5
• 04719872167020: U2 Broach, #5
• 04719872166993: U2 Broach, #4
• 04719872166986: U2 Broach, #4
• 04719872166962: U2 Broach, #3
• 04719872166955: U2 Broach, #3
• 04719872166931: U2 Broach, #2
• 04719872166900: U2 Broach, #1
• 04719872166894: U2 Broach, #1
• 04719872166870: U2 Broach, #0
• 04719872166863: U2 Broach, #0
• 04719872166856: U2 Broach, #0
• 04719872159681: Femoral head trial φ22mm, +9mm
• 04719872159469: Femoral head trial, Ø22mm, +3mm
• 04719872159452: Femoral head trial φ22mm, +3mm
• 04719872159117: Revision hip stem trial, curved, right, Ø18×230mm
• 04719872159100: Revision hip stem trial, curved, right,φ18×230mm
• 04719872159094: Revision hip stem trial, curved, right, Ø16.5×230mm
• 04719872159087: Revision hip stem trial, curved, right,φ16.5×230mm
• 04719872159070: Revision hip stem trial, curved, right, Ø15×230mm
• 04719872159063: Revision hip stem trial, curved, right,φ15×230mm
• 04719872159056: Revision hip stem trial, curved, right, Ø14×230mm
• 04719872159049: Revision hip stem trial, curved, right, φ14×230mm
• 04719872159032: Revision hip stem trial, curved, right, Ø13×230mm
• 04719872159025: Revision hip stem trial, curved, right, φ13×230mm
• 04719872159018: Revision hip stem trial, curved, right, Ø12×230mm