SMR 9CCA.13.012

GUDID 08033390111256

SMR : HEMISPHERICAL HUMERAL REAMER Ø50mm

LIMACORPORATE SPA

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: 08033390111256
• NIH Device Record Key: f5a814a7-2b53-4698-ac69-71b7d4f57720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR
• Version Model Number: HEMISPHERICAL HUMERAL REAMER
• Catalog Number: 9CCA.13.012
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390111256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112900

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

[08033390111256]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-23
• Device Publish Date: 2016-08-05

On-Brand Devices [SMR ]

• 08033390111263: SMR : HEMISPHERICAL HUMERAL REAMER Ø54mm
• 08033390111256: SMR : HEMISPHERICAL HUMERAL REAMER Ø50mm
• 08033390111249: SMR : HEMISPHERICAL HUMERAL REAMER Ø46mm
• 08033390111232: SMR : HEMISPHERICAL HUMERAL REAMER Ø42mm
• 08033390240055: SMR - Modular head plate for press
• 08033390240048: SMR - Modular head pusher for press