Osteotome 260-901-535

GUDID 00813110026019

3.5mm Osteotome

BICON, LLC

Dental osteotome Dental osteotome

• Primary Device ID: 00813110026019
• NIH Device Record Key: 5c7db214-4651-4638-a764-ff3a2ac7580f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteotome
• Version Model Number: 260-901-535
• Catalog Number: 260-901-535
• Company DUNS: 945015758
• Company Name: BICON, LLC
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813110026019 [Primary]

FDA Product Code

• EMM: Chisel, Osteotome, Surgical

Sterilization

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

[00813110026019]

Moist Heat or Steam Sterilization

[00813110026019]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-25
• Device Publish Date: 2016-04-08

On-Brand Devices [Osteotome]

• 00813110026057: 6.0mm Osteotome
• 00813110026040: 5.0mm Osteotome
• 00813110026033: 4.5mm Osteotome
• 00813110026026: 4.0mm Osteotome
• 00813110026019: 3.5mm Osteotome
• 00813110024176: Osteotome Kit