Mini and Micro Fragments Reconstruction System - GMReis 223-27-48-C

GUDID 07899258656724

MINI CORTICAL VERSA SCREW TORXDRIVE TI Ø2,7x48mm

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 07899258656724
• NIH Device Record Key: b94ae121-4eca-4b89-842b-1bbdc684e975
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini and Micro Fragments Reconstruction System - GMReis
• Version Model Number: Mini Cortical Screw
• Catalog Number: 223-27-48-C
• Company DUNS: 900865213
• Company Name: GM DOS REIS INDUSTRIA E COMERCIO LTDA
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899258656724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182718
• Premarket Notification: K243740

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

[07899258656724]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-01
• Device Publish Date: 2024-01-24

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