DiaFlexy-R 21mm 45-80, pu: 6pcs

GUDID 07630049989733

Rotary instrument for endodontic intraoral use

Diaswiss SA

Manual endodontic file/rasp, reusable

• Primary Device ID: 07630049989733
• NIH Device Record Key: 508f58be-a8f1-47c6-9993-33bb063a3053
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiaFlexy-R 21mm 45-80, pu: 6pcs
• Version Model Number: 921021R.4580
• 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	07630049989733 [Primary]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

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

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

Moist Heat or Steam Sterilization

[07630049989733]

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

Devices Manufactured by Diaswiss SA

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• 07630049901087 - Porcelain Veneer Set: 2023-12-11 Dental application set for intraoral use
• 07630049901100 - A-Z Modern Cavity Set: 2023-12-11 Dental application set for intraoral use
• 07630049901391 - RootEX standard 0.8 (sample): 2023-12-11 Endodontic instrument kit for root tip extraction
• 07630049901407 - RootEX standard 011(sample): 2023-12-11 Endodontic instrument kit for root tip extraction
• 07630049901414 - RootEX standard 1.6 (sample): 2023-12-11 Endodontic instrument kit for root tip extraction
• 07630049901421 - RootEX standard 1.8 (sample): 2023-12-11 Endodontic instrument kit for root tip extraction
• 07630049901438 - RootEX standard 0.8 (sample): 2023-12-11 Endodontic instrument kit for root tip extraction