Natus

GUDID 00382830062602

Dantec® DCN Disposable Concentric Needle Electrodes, 2” (50mm) length, Ø 0.46 mm (26G), RED, Single

NATUS MANUFACTURING LIMITED

Electromyographic needle electrode, single-use

• Primary Device ID: 00382830062602
• NIH Device Record Key: bd4162a7-ad10-49ea-b06e-30fc7486bc4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natus
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830050678 [Primary]
GS1	00382830062602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143433

FDA Product Code

• IKT: Electrode, Needle, Diagnostic Electromyograph

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: 2024-04-29
• Device Publish Date: 2024-04-19

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• 00382830050654: Dantec® DCN Disposable Concentric Needle Electrodes, 1” (25mm) length, Ø 0.46 mm (26G), GRN,
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