DURAN®+ A2 pd

GUDID J01834230

DURAN®+ A2 pd 0.75 x 125 mm

Scheu-Dental GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: J01834230
• NIH Device Record Key: 4d32babc-43b7-4176-bf91-68af4e0c5830
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAN®+ A2 pd
• Version Model Number: 3423.1
• Company DUNS: 317683787
• Company Name: Scheu-Dental GmbH
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J01834230 [Unit of Use]
HIBCC	J01834231 [Primary]

FDA Product Code

• KMY: Positioner, Tooth, Preformed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-26
• Device Publish Date: 2024-11-18

On-Brand Devices [DURAN®+ A2 pd]

• J01834240: DURAN®+ A2 pd 0.625 x 125 mm
• J01834230: DURAN®+ A2 pd 0.75 x 125 mm
• J01834220: DURAN®+ A2 pd 0.5 x 125 mm