Delta Dual Mobility System 5566.50.420

GUDID 08033390012447

Mobile Liner Dia. 42 mm for Head Dia. 28 mm

LIMACORPORATE SPA

Non-constrained polyethylene acetabular liner

• Primary Device ID: 08033390012447
• NIH Device Record Key: dd921bb9-7a4a-4d2f-87c3-2b7c8d67fd94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Dual Mobility System
• Version Model Number: 5566.50.420
• Catalog Number: 5566.50.420
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390012447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181491

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-03
• Device Publish Date: 2019-06-25

On-Brand Devices [Delta Dual Mobility System]

• 08033390086332: Liner #M for Mobile Liner Dia. 40 mm
• 08033390086325: Mobile Liner Dia. 40 mm for Head Dia. 28 mm
• 08033390020060: Liner #L for Mobile Liner Dia. 42 mm
• 08033390012447: Mobile Liner Dia. 42 mm for Head Dia. 28 mm