SMR System 1325.09.481

GUDID 08033390274524

SMR System - Humeral Head Dia. 48 mm H. 21 mm

LIMACORPORATE SPA

Stem-fixed humeral head prosthesis

• Primary Device ID: 08033390274524
• NIH Device Record Key: 1e63468a-56ac-4643-b809-65d1c6b31919
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR System
• Version Model Number: 1325.09.481
• Catalog Number: 1325.09.481
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390274524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161476

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-06
• Device Publish Date: 2024-02-27

On-Brand Devices [SMR System]

• 08033390164665: Trial Safety Screw for glenosphere
• 08033390164368: CMI Reamer Guide
• 08033390163873: Wrench Torx T15
• 08033390194617: Stop Guide 30° +5mm
• 08033390270670: SMR System - Glenoid Peg TT Small/Standard X-Long
• 08033390270656: SMR System - Glenoid Peg TT Small/Standard Long
• 08033390270649: SMR System - Glenoid Peg TT Small/Standard Medium
• 08033390270571: SMR System - Glenoid Peg TT Small/Standard Short
• 08033390270564: SMR System - Glenoid Peg TT Small-R X-Long
• 08033390270557: SMR System - Glenoid Peg TT Small-R Long
• 08033390270540: SMR System - Glenoid Peg TT Small-R Medium
• 08033390270533: SMR System - Glenoid Peg TT Small-R Short
• 08033390274555: SMR System - Humeral Head Dia. 54 mm H. 24 mm
• 08033390274548: SMR System - Humeral Head Dia. 52 mm H. 23 mm
• 08033390274531: SMR System - Humeral Head Dia. 50 mm H. 22 mm
• 08033390274524: SMR System - Humeral Head Dia. 48 mm H. 21 mm
• 08033390274517: SMR System - Humeral Head Dia. 46 mm H. 20 mm
• 08033390274494: SMR System - Humeral Head Dia. 44 mm H. 19 mm
• 08033390274487: SMR System - Humeral Head Dia. 42 mm H. 18 mm
• 08033390274470: SMR System - Humeral Head Dia. 40 mm H. 18 mm
• 08033390274463: SMR System - Humeral Head Dia. 54 mm H. 23 mm
• 08033390274456: SMR System - Humeral Head Dia. 52 mm H. 22 mm
• 08033390274449: SMR System - Humeral Head Dia. 50 mm H. 21 mm
• 08033390274432: SMR System - Humeral Head Dia. 54 mm H. 18 mm
• 08033390274425: SMR System - Humeral Head Dia. 48 mm H. 20 mm
• 08033390274401: SMR System - Humeral Head Dia. 46 mm H. 19 mm
• 08033390274357: SMR System - Humeral Head Dia. 44 mm H. 18 mm
• 08033390274340: SMR System - Humeral Head Dia. 42 mm H. 17 mm
• 08033390274326: SMR System - Humeral Head Dia. 40 mm H. 17 mm
• 08033390274319: SMR System - Humeral Head Dia. 54 mm
• 08033390274302: SMR System - Humeral Head Dia. 52 mm H. 17 mm
• 08033390274296: SMR System - Humeral Head Dia. 52 mm
• 08033390274289: SMR System - Humeral Head Dia. 50 mm H. 16mm
• 08033390274272: SMR System - Humeral Head Dia. 50 mm
• 08033390274265: SMR System - Humeral Head Dia. 48 mm H. 15 mm
• 08033390274258: SMR System - Humeral Head Dia. 48 mm
• 08033390274241: SMR System - Humeral Head Dia. 46 mm H. 14 mm
• 08033390274234: SMR System - Humeral Head Dia. 46 mm
• 08033390274197: SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 7mm
• 08033390274166: SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 6mm
• 08033390274159: SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 4mm
• 08033390274142: SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 2mm
• 08033390274081: SMR System - Humeral Head Dia. 44 mm H. 13 mm Neutral
• 08033390274074: SMR System - Humeral Head Dia. 44 mm
• 08033390274067: SMR System - Humeral Head Dia. 42 mm H. 12 mm Eccentrical 6mm
• 08033390274050: SMR System - Humeral Head Dia. 42 mm H. 12 mm Eccentrical 4mm
• 08033390274043: SMR System - Humeral Head Dia. 42 mm H. 12 mm Eccentrical 2mm
• 08033390274036: SMR System - Humeral Head Dia. 42 mm H. 12 mm Neutral
• 08033390274029: SMR System - Humeral Head Dia. 42 mm
• 08033390274012: SMR System - Humeral Head Dia. 40 mm H. 12 mm Eccentrical 4mm