DELTA SYSTEM 9095.11.551

GUDID 08033390152310

Curved Cup Impactor Reduced Offset

LIMACORPORATE SPA

Orthopaedic implant impactor

• Primary Device ID: 08033390152310
• NIH Device Record Key: b1fcd35e-854f-4991-b238-66211bddd070
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTA SYSTEM
• Version Model Number: 9095.11.551
• Catalog Number: 9095.11.551
• 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	08033390152310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112898

FDA Product Code

• MBL: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Sterilization

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

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

[08033390152310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-03
• Device Publish Date: 2019-06-25

Devices Manufactured by LIMACORPORATE SPA

• 08033390290654 - TEMA Elbow: 2024-12-30 TEMA Elbow - T15 Screwdriver Shaft for Axle Removal
• 08033390290661 - TEMA Elbow: 2024-12-30 TEMA Elbow - Sleeve for Axle Removal Large
• 08033390290678 - TEMA Elbow: 2024-12-30 TEMA Elbow - Sleeve for Axle Removal Small
• 08033390282642 - ProMade Shoulder: 2024-08-15 ProMade Shoulder - Long Helix Drill Dia. 3,5 mm
• 08033390282659 - ProMade Shoulder: 2024-08-15 ProMade Shoulder - Guide for Long Helix Drill Dia. 3,5 mm
• 08033390134415 - SMR Shoulder: 2024-08-06 SMR Shoulder - Removal Pliers
• 08033390080637 - SMR Shoulder: 2024-08-05 SMR Shoulder - Reverse liners 36mm (UHMWPE) +6mm
• 08033390085502 - NA: 2024-08-05 Curved Depth Gauge