RootEX standard 1.6 (sample)

GUDID 07630049901469

Endodontic instrument kit for root tip extraction

Diaswiss SA

Endodontic enlarger, reusable

• Primary Device ID: 07630049901469
• NIH Device Record Key: cd2c4c1d-9a15-45bc-a904-7eb900e59741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RootEX standard 1.6 (sample)
• Version Model Number: 935K.Set016-sam
• 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	07630049901469 [Primary]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

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

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

Moist Heat or Steam Sterilization

[07630049901469]

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

On-Brand Devices [RootEX standard 1.6 (sample)]

• 07630049901469: Endodontic instrument kit for root tip extraction
• 07630049901414: Endodontic instrument kit for root tip extraction