Dantec

GUDID 05704736002882

DantecTM DCN

NATUS MANUFACTURING LIMITED

Electromyographic needle electrode, single-use

• Primary Device ID: 05704736002882
• NIH Device Record Key: b2ebe18d-b7c4-40b6-bd6f-af172a82d9e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dantec
• Version Model Number: 9013S0042
• Company DUNS: 896421240
• Company Name: NATUS MANUFACTURING LIMITED
• 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	05704736002882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112034

FDA Product Code

• IKT: Electrode, Needle, Diagnostic Electromyograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-25

On-Brand Devices [Dantec]

• 00382830041232: Holder for Dantec™ DCN Disposable Concentric Needle Electrodes
• 05704736002899: DantecTM DCN
• 05704736002882: DantecTM DCN
• 05704736002875: DantecTM DCN
• 05704736002868: DantecTM DCN