Head Impactor 9095.11.110

GUDID 08033390085281

Head Impactor

LIMACORPORATE SPA

Orthopaedic implant impactor, reusable

• Primary Device ID: 08033390085281
• NIH Device Record Key: 1973ced1-0778-42be-9e57-caec23dd375a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Head Impactor
• Version Model Number: Head Impactor
• Catalog Number: 9095.11.110
• 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	08033390085281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140975

FDA Product Code

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

Sterilization

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

[08033390085281]

Moist Heat or Steam Sterilization

[08033390085281]

Moist Heat or Steam Sterilization

[08033390085281]

Moist Heat or Steam Sterilization

[08033390085281]

Moist Heat or Steam Sterilization

[08033390085281]

Moist Heat or Steam Sterilization

[08033390085281]

Moist Heat or Steam Sterilization

[08033390085281]

Moist Heat or Steam Sterilization

[08033390085281]

Moist Heat or Steam Sterilization

[08033390085281]

Moist Heat or Steam Sterilization

[08033390085281]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2026-02-09
• Device Publish Date: 2016-08-05

Devices Manufactured by LIMACORPORATE SPA

• 08033390002233 - SMR System: 2026-02-27 SMR System - Reverse HP Liner Short Dia. 44mm
• 08033390002240 - SMR System: 2026-02-27 SMR System - Reverse HP Liner Medium Dia. 44mm
• 08033390002257 - SMR System: 2026-02-27 SMR System - Reverse HP Liner Long Dia. 44mm
• 08033390050029 - SMR System: 2026-02-27 SMR System - Reverse HP Lateralizing Liner Medium Dia. 44mm
• 08033390050036 - SMR System: 2026-02-27 SMR System - Reverse HP Lateralizing Liner Long Dia. 44mm
• 08033390191135 - PRIMA: 2026-02-27 PRIMA - Reverse Insert # LONG Dia. 44mm 7°Corr.
• 08033390201971 - PRIMA: 2026-02-27 PRIMA - Reverse Insert # SHORT Dia. 40mm 0°Corr.
• 08033390202299 - PRIMA: 2026-02-27 PRIMA - Reverse Insert # MEDIUM Dia. 40mm 0°Corr.