Coaxial needle

GUDID 04260277172008

Möller Medical GmbH

Nonimplantable needle guide, single-use

• Primary Device ID: 04260277172008
• NIH Device Record Key: af12974f-7130-423e-8c10-f1c9bcafff46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coaxial needle
• Version Model Number: COX-1040-18-0043
• 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	04260277171919 [Primary]
GS1	04260277172008 [Package]; Contains: 04260277171919; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-08-17

On-Brand Devices [Coaxial needle]

• 04260277178161: COX-2020-18-0149
• 04260277178154: COX-2020-18-0109
• 04260277178147: COX-2020-18-0049
• 04260277177935: COX-2020-16-0149
• 04260277177928: COX-2020-16-0109
• 04260277177911: COX-2020-16-0049
• 04260277175559: COX-2000-16-0251
• 04260277175535: COX-2000-16-0201
• 04260277175511: COX-2000-14-0251
• 04260277175498: COX-2000-14-0201
• 04260277175474: COX-2000-20-0251
• 04260277175450: COX-2000-20-0201
• 04260277175436: COX-2000-18-0251
• 04260277175412: COX-2020-16-0142
• 04260277175405: COX-2020-16-0102
• 04260277175399: COX-2020-16-0092
• 04260277175382: COX-2020-16-0042
• 04260277175337: COX-2000-14-0151
• 04260277175320: COX-2000-14-0101
• 04260277175313: COX-2000-14-0051
• 04260277175306: COX-2000-16-0151
• 04260277175290: COX-2000-16-0101
• 04260277175283: COX-2000-16-0051
• 04260277175276: COX-2000-18-0201
• 04260277175269: COX-2000-18-0151
• 04260277175252: COX-2000-18-0101
• 04260277175245: COX-2000-18-0051
• 04260277175238: COX-2000-20-0151
• 04260277175221: COX-2000-20-0101
• 04260277175085: COX-2000-20-0051
• 04260277172060: COX-1040-14-0103
• 04260277172053: COX-1040-14-0043
• 04260277172046: COX-1040-16-0103
• 04260277172039: COX-1040-16-0043
• 04260277172022: COX-1040-18-0143
• 04260277172015: COX-1040-18-0103
• 04260277172008: COX-1040-18-0043
• 04260277171995: COX-1040-20-0106
• 04260277171988: COX-1040-20-0046
• 04260277171889: COX-1030-14-0075
• 04260277171872: COX-1030-14-0035
• 04260277171865: COX-1030-16-0115
• 04260277171858: COX-1030-16-0075
• 04260277171841: COX-1030-16-0035
• 04260277171834: COX-1030-18-0115
• 04260277171827: COX-1030-18-0075
• 04260277171810: COX-1030-18-0035
• 04260277171803: COX-1030-20-0118
• 04260277171797: COX-1030-20-0078
• 04260277171780: COX-1030-20-0038