Biologic 101605

GUDID 00382830052160

Square Square Snap Electrodes - aggressive adhesion (not for use on infants)

NATUS MEDICAL INCORPORATED

Analytical scalp electrode, single-use

• Primary Device ID: 00382830052160
• NIH Device Record Key: deb2da7c-3aac-4cf5-99f3-3bc3fbd646f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biologic
• Version Model Number: Disposable Electrodes
• Catalog Number: 101605
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• Device Count: 300
• 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: false
• 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

Customer Support Contacts

• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830043908 [Unit of Use]
GS1	00382830052160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030823

FDA Product Code

• EWO: Audiometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-31

Devices Manufactured by NATUS MEDICAL INCORPORATED

• 00382830050517 - NATUS EXTERNAL DRAINAGE VENTRICULAR CATHETER SET: 2024-11-08 NATUS EXTERNAL DRAINAGE VENTRICULAR CATHETER SET
• 00382830050524 - NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER: 2024-11-08 NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER
• 00382830050531 - NATUS LUMBAR CATHETER KIT: 2024-11-08 NATUS LUMBAR CATHETER KIT
• 00382830050548 - NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER: 2024-11-08 NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER
• 00382830050555 - NATUS EDS3 DRAINAGE SYSTEM: 2024-11-08 NATUS EDS3 DRAINAGE SYSTEM
• 00382830050562 - NATUS EDS3 COLLECT BAG KIT 5 BAGS: 2024-11-08 NATUS EDS3 COLLECT BAG KIT 5 BAGS
• 00382830050579 - NATUS EDS3 LEVELING DEVICE: 2024-11-08 NATUS EDS3 LEVELING DEVICE
• 00382830050593 - NATUS EDS3 LUMBAR CATHETER KIT: 2024-11-08 NATUS EDS3 LUMBAR CATHETER KIT