Endodrill Biopsy instrument 13001

GUDID 27340179900051

Sterile single use biopsi instrument GI to be used with Endodrill® Drive System. The EndoDrill® GI is a surgical instrument intended to collect tissue for histological examination through a flexible endoscope.

Bibbinstruments AB

General-purpose endoscopic needle, single-use

• Primary Device ID: 27340179900051
• NIH Device Record Key: 96530cf2-92b8-42ea-aa13-265d755759ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endodrill Biopsy instrument
• Version Model Number: GI 17G
• Catalog Number: 13001
• 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: 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	27340179900051 [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: true

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

On-Brand Devices [Endodrill Biopsy instrument ]

• 37340179900058: Sterile single use biopsi instrument GI to be used with Endodrill® Drive system. The EndoDrillÂ
• 27340179900051: Sterile single use biopsi instrument GI to be used with Endodrill® Drive System. The EndoDrillÂ
• 17340179900054: Sterile single use biopsi instrument GI to be used with Endodrill drive system. The EndoDrill®