Acetabular Instrument Set 9057.20.555

GUDID 08033390025744

Beater-Positioner-Aligner

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 08033390025744
• NIH Device Record Key: 2993bdfb-4231-482b-90fa-f08d2c535c81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acetabular Instrument Set
• Version Model Number: Beater-Positioner-Aligner
• Catalog Number: 9057.20.555
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390025744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112158

FDA Product Code

• KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Sterilization

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

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

[08033390025744]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-06-17

On-Brand Devices [Acetabular Instrument Set]

• 08033390066198: Liner Positioner LARGE Dia.40 mm
• 08033390066181: Liner Positioner MEDIUM-LARGE Dia.36 mm
• 08033390066174: Liner Positioner SMALL Dia.32 mm
• 08033390064576: 45° Joint for Beater
• 08033390064569: Joint for Ceramic Liner Posititioner
• 08033390063364: 45° Joint for Ceramic Liner Posititioner
• 08033390025744: Beater-Positioner-Aligner
• 08033390137126: Cannulated Handle M6 with Flange