Franseen needle

GUDID 04260277172640

Möller Medical GmbH

Soft-tissue biopsy needle, single-use

• Primary Device ID: 04260277172640
• NIH Device Record Key: 5401036a-eb7b-4b5f-b8a0-96f277f0044c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Franseen needle
• Version Model Number: FNB-1003-22-0090
• Company DUNS: 320405061
• Company Name: Möller Medical GmbH
• 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	04260277172558 [Primary]
GS1	04260277172640 [Package]; Contains: 04260277172558; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162588

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: 2018-09-17
• Device Publish Date: 2018-08-17

On-Brand Devices [Franseen needle]

• 04260277172725: FNB-1003-18-0200
• 04260277172718: FNB-1003-18-0150
• 04260277172701: FNB-1003-18-0090
• 04260277172695: FNB-1003-20-0200
• 04260277172688: FNB-1003-20-0150
• 04260277172671: FNB-1003-20-0090
• 04260277172664: FNB-1003-22-0200
• 04260277172657: FNB-1003-22-0150
• 04260277172640: FNB-1003-22-0090