Natus

GUDID 00382830062572

Dantec® DCN Disposable Concentric Needle Electrodes, 1” (25mm) length, Ø 0.30 mm (30G), ORG, Single

NATUS MANUFACTURING LIMITED

Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use

Primary Device ID	00382830062572
NIH Device Record Key	a9ea3650-262f-4da4-a8a9-41eabd75a7db
Commercial Distribution Status	In Commercial Distribution
Brand Name	Natus
Version Model Number	9013S0012
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	00382830050647 [Primary]
GS1	00382830062572 [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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