Endodrill Drive System 3000-01

GUDID 17340179900078

Endodrill Drive System is to be used with Endodrill Biopsy Instrument GI . Endodrill System is a surgical instrument used together with a flexible ultrasound endoscope to collect tissue for histological examination.

Bibbinstruments AB

General-purpose endoscopic needle, single-use

• Primary Device ID: 17340179900078
• NIH Device Record Key: 6c7af4e2-3211-4f1f-b481-3e71a38a645f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endodrill Drive System
• Version Model Number: Model X
• Catalog Number: 3000-01
• Company DUNS: 352499168
• Company Name: Bibbinstruments AB
• 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: false
• Lot Batch: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	17340179900078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212423

FDA Product Code

• FCG: Biopsy Needle

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: 2024-02-08
• Device Publish Date: 2024-01-31

Devices Manufactured by Bibbinstruments AB

• 17340179900054 - Endodrill Biopsy instrument: 2024-02-08 Sterile single use biopsi instrument GI to be used with Endodrill drive system. The EndoDrill® GI is a surgical instrument int
• 17340179900078 - Endodrill Drive System: 2024-02-08Endodrill Drive System is to be used with Endodrill Biopsy Instrument GI . Endodrill System is a surgical instrument used together with a flexible ultrasound endoscope to collect tissue for histological examination.
• 17340179900078 - Endodrill Drive System: 2024-02-08 Endodrill Drive System is to be used with Endodrill Biopsy Instrument GI . Endodrill System is a surgical instrument used togeth
• 27340179900051 - Endodrill Biopsy instrument: 2024-02-08 Sterile single use biopsi instrument GI to be used with Endodrill® Drive System. The EndoDrill® GI is a surgical instrument i
• 37340179900058 - Endodrill Biopsy instrument: 2024-02-08 Sterile single use biopsi instrument GI to be used with Endodrill® Drive system. The EndoDrill® GI is a surgical instrument i