rootEX set short 1,1mm, pu: 1 drill 1,

GUDID 07630049952645

Endodontic instrument kit for root tip extraction

Diaswiss SA

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• Primary Device ID: 07630049952645
• NIH Device Record Key: ac2c1876-a0ea-49ac-ab23-26c4fc4d3ca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rootEX set short 1,1mm, pu: 1 drill 1,
• Version Model Number: 935K.Set011
• Company DUNS: 480296552
• Company Name: Diaswiss SA
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630049952645 [Primary]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

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

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

[07630049952645]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-11
• Device Publish Date: 2023-12-01

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• 07630049901421 - RootEX standard 1.8 (sample): 2023-12-11 Endodontic instrument kit for root tip extraction
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