R3FLEX 2.8mm Cannulated Drill w/ 1.6mm Steinmann Pin P82-912-0000-SK

GUDID 14053613293065

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bur, single-use

• Primary Device ID: 14053613293065
• NIH Device Record Key: bbc39ed2-3482-4ebd-aea7-35f5e984e8bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R3FLEX 2.8mm Cannulated Drill w/ 1.6mm Steinmann Pin
• Version Model Number: P82-912-0000-SK
• Catalog Number: P82-912-0000-SK
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	14053613293065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• GFF: Bur, Surgical, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-15
• Device Publish Date: 2025-04-07

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• E226007158R18 - KOMET Root Canal Files: 2025-12-18
• E226007159R18 - KOMET Root Canal Files: 2025-12-18