Hip 9046.10.230

GUDID 08033390032094

Stem Positioner - H-Max Instrument

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 08033390032094
• NIH Device Record Key: a344661d-7902-4626-9057-1d94ea897740
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hip
• Version Model Number: Stem Positioner
• Catalog Number: 9046.10.230
• 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	08033390032094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112091

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

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

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

Moist Heat or Steam Sterilization

[08033390032094]

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: 2016-07-27

Devices Manufactured by LIMACORPORATE SPA

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• 08033390001380 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.44mm
• 08033390001397 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.46mm
• 08033390001403 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.48mm
• 08033390001410 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.50mm
• 08033390001427 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.52mm
• 08033390001434 - SMR Shoulder: 2025-03-06 Humeral heads (CoCrMo) dia.54mm
• 08033390001557 - SMR Shoulder: 2025-03-06 CTA humeral heads (CoCrMo) dia.42mm