Cannulated Humeral Head Impactor 9C13.22.100

GUDID 08033390104685

Cannulated Humeral Head Impactor - SMR Shoulder

LIMACORPORATE SPA

Orthopaedic implant impactor, reusable

• Primary Device ID: 08033390104685
• NIH Device Record Key: 4d84776a-8c45-4409-a095-ed3f66d03d25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated Humeral Head Impactor
• Version Model Number: Humeral Head Impactor
• Catalog Number: 9C13.22.100
• 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	08033390104685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100858

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[08033390104685]

Moist Heat or Steam Sterilization

[08033390104685]

Moist Heat or Steam Sterilization

[08033390104685]

Moist Heat or Steam Sterilization

[08033390104685]

Moist Heat or Steam Sterilization

[08033390104685]

Moist Heat or Steam Sterilization

[08033390104685]

Moist Heat or Steam Sterilization

[08033390104685]

Moist Heat or Steam Sterilization

[08033390104685]

Moist Heat or Steam Sterilization

[08033390104685]

Moist Heat or Steam Sterilization

[08033390104685]

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.