Chiba needle

GUDID 04260277172237

Möller Medical GmbH

Soft-tissue biopsy needle, single-use

• Primary Device ID: 04260277172237
• NIH Device Record Key: 5c972b31-f1f0-449b-aab8-98b454add555
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chiba needle
• Version Model Number: FNB-1001-23-0150
• 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	04260277172107 [Primary]
GS1	04260277172237 [Package]; Contains: 04260277172107; 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 [Chiba needle]

• 04260277174781: FNB-1001-22-0110
• 04260277172329: FNB-1001-18-0200
• 04260277172312: FNB-1001-18-0150
• 04260277172305: FNB-1001-18-0090
• 04260277172299: FNB-1001-20-0200
• 04260277172282: FNB-1001-20-0150
• 04260277172275: FNB-1001-20-0090
• 04260277172268: FNB-1001-22-0200
• 04260277172251: FNB-1001-22-0150
• 04260277172244: FNB-1001-22-0090
• 04260277172237: FNB-1001-23-0150
• 04260277172220: FNB-1001-23-0090
• 04260277172213: FNB-1001-25-0150
• 04260277172206: FNB-1001-25-0090