Steel burs cavity cylindric round D002814000700

GUDID J003D0028140007001

STEEL BURS CYL. ROUND HP 007

MAILLEFER INSTRUMENTS HOLDING Sàrl

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• Primary Device ID: J003D0028140007001
• NIH Device Record Key: b7b183ba-a8d2-44c4-b30b-9833a5fe6a3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steel burs cavity cylindric round
• Version Model Number: D002814000700
• Catalog Number: D002814000700
• Company DUNS: 480538495
• Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J003D0028140007001 [Primary]

FDA Product Code

• EJL: BUR, DENTAL

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: 2022-11-28
• Device Publish Date: 2022-11-20

On-Brand Devices [Steel burs cavity cylindric round]

• J003D0028240016001: STEEL BURS CYL. ROUND RA 016
• J003D0028240012001: STEEL BURS CYL. ROUND RA 012
• J003D0028140018001: STEEL BURS CYL. ROUND HP 018
• J003D0028140010001: STEEL BURS CYL. ROUND HP 010
• J003D0028140007001: STEEL BURS CYL. ROUND HP 007