U2™ Hip 9104-6030-RC

GUDID 04719872156802

U2 Broach, #3

UNITED ORTHOPEDIC CORP.

Orthopaedic broach

• Primary Device ID: 04719872156802
• NIH Device Record Key: 12767212-ca28-4462-9aca-8a36e92587fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2™ Hip
• Version Model Number: 9104-6030-RC
• Catalog Number: 9104-6030-RC
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• Device Count: 1
• DM Exempt: true
• 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	04719872156802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111546

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

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

[04719872156802]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-15

On-Brand Devices [U2™ Hip]

• 04719872179245: U2 Cup liner impactor, I.D. 28mm
• 04719872179238: U2 Cup liner impactor, I.D. 26mm
• 04719872179122: Broach handle
• 04719872179115: Neck trial, #0
• 04719872179108: Stem impactor, long
• 04719872177876: U2 XPE case
• 04719872173830: Cup impactor, offset
• 04719872173816: Cup reamer handle, offset
• 04719872173755: Size plate, XPE hip
• 04719872173496: Flexible drill, 50mm
• 04719872173472: Flexible drill, 35mm
• 04719872173458: Flexible drill, 25mm
• 04719872173434: Flexible drill, 15mm
• 04719872173410: Cup reamer, 70mm
• 04719872173403: Cup reamer, 69mm
• 04719872173397: Cup reamer, 68mm
• 04719872173380: Cup reamer, 67mm
• 04719872173373: Cup reamer, 66mm
• 04719872173366: Cup reamer, 65mm
• 04719872173359: Cup reamer, 64mm
• 04719872173342: Cup reamer, 63mm
• 04719872173335: Cup reamer, 62mm
• 04719872173328: Cup reamer, 61mm
• 04719872173311: Cup reamer, 60mm
• 04719872173304: Cup reamer, 59mm
• 04719872173298: Cup reamer, 58mm
• 04719872173281: Cup reamer, 57mm
• 04719872173274: Cup reamer, 56mm
• 04719872173267: Cup reamer, 55mm
• 04719872173250: Cup reamer, 54mm
• 04719872173243: Cup reamer, 53mm
• 04719872173236: Cup reamer, 52mm
• 04719872173229: Cup reamer, 51mm
• 04719872173212: Cup reamer, 50mm
• 04719872173205: Cup reamer, 49mm
• 04719872173199: Cup reamer, 48mm
• 04719872173182: Cup reamer, 47mm
• 04719872173175: Cup reamer, 46mm
• 04719872173168: Cup reamer, 45mm
• 04719872173151: Cup reamer, 44mm
• 04719872173144: Cup reamer, 43mm
• 04719872173137: Cup reamer, 42mm
• 04719872173120: Cup reamer, 41mm
• 04719872173113: Cup reamer, 40mm
• 04719872173106: Cup reamer, 39mm
• 04719872173090: Cup reamer, 38mm
• 04719872173083: Cup reamer, 37mm
• 04719872173076: Cup reamer, 36mm
• 04719872173069: Cup locator block
• 04719872173052: Full XPE cup positioner