SMR STEMLESS 9013.55.039

GUDID 08033390108065

SMR STEMLESS - Reamer Shaft

LIMACORPORATE SPA

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 08033390108065
• NIH Device Record Key: 24d3069e-23aa-46f8-8eb7-3fcd49775b7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR STEMLESS
• Version Model Number: 9013.55.039
• Catalog Number: 9013.55.039
• 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	08033390108065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212800

FDA Product Code

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

Sterilization

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

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

[08033390108065]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-25
• Device Publish Date: 2022-03-17

On-Brand Devices [SMR STEMLESS]

• 08033390108065: SMR STEMLESS - Reamer Shaft
• 08033390192132: SMR STEMLESS Shoulder - K-Wire Centering Sleeve Extended
• 08033390109925: SMR STEMLESS Shoulder - #X-LARGE Introducer
• 08033390109918: SMR STEMLESS Shoulder - #LARGE Introducer
• 08033390109901: SMR STEMLESS Shoulder - #MEDIUM Introducer
• 08033390109895: SMR STEMLESS - Introducer SMALL
• 08033390109888: SMR STEMLESS Shoulder - #X-SMALL Introducer
• 08033390109857: SMR STEMLESS Shoulder - #X-LARGE Sizer
• 08033390109840: SMR STEMLESS - Sizer Large
• 08033390109833: SMR STEMLESS - Sizer Medium
• 08033390109826: SMR STEMLESS - Sizer Small
• 08033390109819: SMR STEMLESS Shoulder - #X-SMALL Sizer
• 08033390108294: SMR STEMLESS Shoulder - #X-LARGE Stemless Core Removal Reamer
• 08033390108287: SMR STEMLESS - #X-SMALL Stemless Core Removal Reamer
• 08033390108270: SMR STEMLESS Shoulder - #X-LARGE Compactor
• 08033390108263: SMR STEMLESS - Compactor Large
• 08033390108256: SMR STEMLESS - Compactor Medium
• 08033390108249: SMR STEMLESS - Compactor Small
• 08033390108232: SMR STEMLESS Shoulder - #X-SMALL Compactor
• 08033390108225: SMR STEMLESS Shoulder - #X-LARGE Short Compactor
• 08033390108218: SMR STEMLESS - Compactor Large Short
• 08033390108201: SMR STEMLESS - Compactor Medium Short
• 08033390108195: SMR STEMLESS - Compactor Small Short
• 08033390108188: SMR STEMLESS Shoulder - #X-SMALL Short Compactor
• 08033390108164: SMR STEMLESS Shoulder - #X-LARGE Reamer
• 08033390108157: SMR STEMLESS - Reamer Large
• 08033390108140: SMR STEMLESS - Reamer Medium
• 08033390108133: SMR STEMLESS - Reamer Small
• 08033390108126: SMR STEMLESS Shoulder - #X-SMALL Reamer
• 08033390108119: SMR STEMLESS Shoulder - #X-LARGE Short Reamer
• 08033390108102: SMR STEMLESS - Reamer Large Short
• 08033390108096: SMR STEMLESS - Reamer Medium Short
• 08033390108089: SMR STEMLESS - Reamer Small Short
• 08033390108072: SMR STEMLESS Shoulder - #X-SMALL Short Reamer
• 08033390108058: SMR STEMLESS Shoulder - Cutting Template
• 08033390108041: SMR STEMLESS Shoulder - Connector for Trial Adaptors
• 08033390107877: SMR STEMLESS - STEMLESS CORE # X-LARGE
• 08033390107860: SMR STEMLESS - STEMLESS CORE # LARGE
• 08033390107853: SMR STEMLESS - STEMLESS CORE # MEDIUM
• 08033390107846: SMR STEMLESS - STEMLESS CORE # SMALL
• 08033390107839: SMR STEMLESS - STEMLESS CORE # X-SMALL
• 08033390107822: SMR STEMLESS - STEMLESS CORE # X-LARGE SHORT
• 08033390107815: SMR STEMLESS - STEMLESS CORE # LARGE SHORT
• 08033390107808: SMR STEMLESS - STEMLESS CORE # MEDIUM SHORT
• 08033390107792: SMR STEMLESS - STEMLESS CORE # SMALL SHORT
• 08033390107785: SMR STEMLESS - STEMLESS CORE # X-SMALL SHORT
• 08033390107778: SMR STEMLESS - 4MM ECCENTRICAL ADAPTOR WITH SCREW
• 08033390107730: SSMR STEMLESS - 2MM ECCENTRICAL ADAPTOR WITH SCREW
• 08033390107723: SMR STEMLESS - NEUTRAL ADAPTOR WITH SCREW
• 08033390100663: SMR STEMLESS - Core Removal Reamer Large