Natus

GUDID 00382830048323

Handheld Bipolar Stimulator

NATUS MANUFACTURING LIMITED

Analytical scalp electrode, reusable

• Primary Device ID: 00382830048323
• NIH Device Record Key: 0a2e2e76-279e-4c6c-815e-1b66a20fd0c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natus
• Version Model Number: 9013L0362
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830048323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934580

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-16
• Device Publish Date: 2020-07-08

On-Brand Devices [Natus]

• 00382830049559: REPLACEMENT FELT TIPS, 7.5MM
• 00382830048323: Handheld Bipolar Stimulator
• 00382830047722: Extension cable for goggles
• 00382830062619: Dantec® DCN Disposable Concentric Needle Electrodes, 3” (75mm) length, Ø 0.64 mm (23G), YEL,
• 00382830062602: Dantec® DCN Disposable Concentric Needle Electrodes, 2” (50mm) length, Ø 0.46 mm (26G), RED
• 00382830062596: Dantec® DCN Disposable Concentric Needle Electrodes, 1.5” (37mm) length, Ø 0.46 mm (26G), BL
• 00382830062589: Dantec® DCN Disposable Concentric Needle Electrodes, 1” (25mm) length, Ø 0.46 mm (26G), GRN,
• 00382830062572: Dantec® DCN Disposable Concentric Needle Electrodes, 1” (25mm) length, Ø 0.30 mm (30G), ORG,
• 00382830050654: Dantec® DCN Disposable Concentric Needle Electrodes, 1” (25mm) length, Ø 0.46 mm (26G), GRN,
• 00382830049436: Flex Arm with Clamp, 40 cm
• 00382830049412: Cart for Notebook PC
• 00382830049405: CART FOR FOCUS DESKTOP SYSTEM OEM KNRR
• 00382830047371: Holder Dantec DCN 1.5M