Acetabular Instrument Set 9CC0.95.032

GUDID 08033390137126

Cannulated Handle M6 with Flange

LIMACORPORATE SPA

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 08033390137126
• NIH Device Record Key: 7d8449a4-b7bb-4f97-af59-e358b08493eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acetabular Instrument Set
• Version Model Number: 9CC0.95.032
• Catalog Number: 9CC0.95.032
• 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	08033390137126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112158

FDA Product Code

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

Sterilization

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

[08033390137126]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-04
• Device Publish Date: 2020-04-24

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