RealGUIDE Z3D Mouth opening gauge

GUDID 08050038831857

3DIEMME SRL

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 08050038831857
• NIH Device Record Key: e2e657fb-7b13-4006-83a5-6189210c32b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RealGUIDE Z3D Mouth opening gauge
• Version Model Number: 3DM00622ZUS
• Company DUNS: 857172105
• Company Name: 3DIEMME SRL
• Device Count: 1
• DM Exempt: false
• 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	08050038831857 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

[08050038831857]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-22
• Device Publish Date: 2022-07-14

Devices Manufactured by 3DIEMME SRL

• 08050038832144 - RealGUIDE™ Z3D KIT, Empty Tray: 2024-12-16
• 08050038833165 - AZURE TAPERED BONE LEVEL GUIDED SURGICAL TRAY, EMPTY: 2024-12-16
• 18050038833094 - RealGUIDE Sleeve: 2024-06-06
• 18050038833100 - RealGUIDE Sleeve: 2024-06-06
• 18050038833117 - RealGUIDE Sleeve: 2024-06-06
• 18050038830192 - RealGUIDE Sleeve: 2024-05-02
• 18050038830208 - RealGUIDE Sleeve: 2024-05-02
• 18050038830222 - RealGUIDE Sleeve: 2024-05-02