Bone Acess Needle FS-DBANJ1106TL

GUDID B183FSDBANJ1106TL0

Bone Access Needle 11ga x 6in

FLOSPINE LLC

Bone access cannula

• Primary Device ID: B183FSDBANJ1106TL0
• NIH Device Record Key: c1fa563e-4166-4f29-94c6-a1155d9e33a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Acess Needle
• Version Model Number: FS-DBANJ1106TL
• Catalog Number: FS-DBANJ1106TL
• Company DUNS: 042993143
• Company Name: FLOSPINE LLC
• 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

Customer Support Contacts

• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com
• Phone: (561)705-3080
• Email: info@flospine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B183FSDBANJ1106TL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141850

FDA Product Code

• KNW: Instrument, Biopsy

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: 2025-04-14
• Device Publish Date: 2025-04-04

On-Brand Devices [Bone Acess Needle]

• B183FSDBANJ1106TL0: Bone Access Needle 11ga x 6in
• B183FSDBANJ0806TL0: Bone Acess Needle 8ga x 6in