Bendit®21 Microcatheter

GUDID 17290018072049

The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.

BEND IT TECHNOLOGIES LTD

Vascular microcatheter

• Primary Device ID: 17290018072049
• NIH Device Record Key: 000629eb-7efb-4412-af02-11bc5fdddc77
• Commercial Distribution Discontinuation: 2050-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bendit®21 Microcatheter
• Version Model Number: BDT21157U2
• Company DUNS: 600476669
• Company Name: BEND IT TECHNOLOGIES LTD
• 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: true
• 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: 13152073508
• Email: info@bendittech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290018072049 [Primary]
GS1	27290018072046 [Package]; Package: Carton box [1 Units]; Discontinued: 2050-12-31; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203842

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

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: 2022-06-17
• Device Publish Date: 2022-06-09

Devices Manufactured by BEND IT TECHNOLOGIES LTD

• 17290018072049 - Bendit®21 Microcatheter: 2022-06-17The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.
• 17290018072049 - Bendit®21 Microcatheter: 2022-06-17 The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculatur
• 17290018072001 - Bendit2.7 Steerable Microcatheter: 2020-09-01 The Bendit2.7™ Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcathe