Disposable needle for reusable biopsy gun

GUDID 04260277170660

Möller Medical GmbH

Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use

• Primary Device ID: 04260277170660
• NIH Device Record Key: 5f2a0c49-0310-4676-9307-7caf1b7fc35e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable needle for reusable biopsy gun
• Version Model Number: DNG-1020-16-0250
• 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	04260277170509 [Primary]
GS1	04260277170660 [Package]; Contains: 04260277170509; 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 [Disposable needle for reusable biopsy gun]

• 04260277171308: DNG-1030-14-0160
• 04260277171292: DNG-1030-14-0120
• 04260277171285: DNG-1030-14-0080
• 04260277171278: DNG-1030-16-0160
• 04260277171261: DNG-1030-16-0120
• 04260277171254: DNG-1030-16-0080
• 04260277171247: DNG-1030-18-0160
• 04260277171230: DNG-1030-18-0120
• 04260277171223: DNG-1030-18-0080
• 04260277171216: DNG-1030-20-0160
• 04260277171209: DNG-1030-20-0120
• 04260277171193: DNG-1030-20-0080
• 04260277171063: DNG-1040-14-0200
• 04260277171056: DNG-1040-14-0160
• 04260277171049: DNG-1040-14-0130
• 04260277171032: DNG-1040-14-0100
• 04260277171025: DNG-1040-16-0200
• 04260277170837: DNG-1040-16-0160
• 04260277171001: DNG-1040-16-0130
• 04260277170998: DNG-1040-16-0100
• 04260277170981: DNG-1040-18-0300
• 04260277170974: DNG-1040-18-0250
• 04260277170967: DNG-1040-18-0200
• 04260277170950: DNG-1040-18-0160
• 04260277170943: DNG-1040-18-0130
• 04260277170936: DNG-1040-18-0100
• 04260277170929: DNG-1040-20-0200
• 04260277170912: DNG-1040-20-0160
• 04260277170905: DNG-1040-20-0130
• 04260277170899: DNG-1040-20-0100
• 04260277170707: DNG-1020-14-0200
• 04260277170691: DNG-1020-14-0160
• 04260277170684: DNG-1020-14-0120
• 04260277170677: DNG-1020-14-0100
• 04260277170660: DNG-1020-16-0250
• 04260277170653: DNG-1020-16-0200
• 04260277170646: DNG-1020-16-0160
• 04260277170639: DNG-1020-16-0100
• 04260277170622: DNG-1020-18-0300
• 04260277170615: DNG-1020-18-0250
• 04260277170608: DNG-1020-18-0200
• 04260277170592: DNG-1020-18-0160
• 04260277170585: DNG-1020-18-0100
• 04260277170578: DNG-1020-20-0200
• 04260277170561: DNG-1020-20-0160
• 04260277170554: DNG-1020-20-0100
• 04260277170387: DNG-1010-14-0200
• 04260277170370: DNG-1010-14-0160
• 04260277170363: DNG-1010-14-0120
• 04260277170356: DNG-1010-14-0100