SPH Cups 9057.20.310

GUDID 08033390025690

Liner Impactor for Dia=32mm Heads - Acetabular Cup

LIMACORPORATE SPA

Orthopaedic implant impactor, reusable

• Primary Device ID: 08033390025690
• NIH Device Record Key: 5334ae4e-15a6-4da9-9bb3-917f2da40c02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPH Cups
• Version Model Number: Liner Impactor
• Catalog Number: 9057.20.310
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390025690 [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

[08033390025690]

Moist Heat or Steam Sterilization

[08033390025690]

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: 2016-07-27

On-Brand Devices [SPH Cups]

• 08033390025690: Liner Impactor for Dia=32mm Heads - Acetabular Cup
• 08033390025683: Liner Impactor for Dia=28mm Heads - Acetabular Cup