Clavis 9015A0012

GUDID 00382830049702

CLAVISTM

NATUS MANUFACTURING LIMITED

Nerve-locating system

• Primary Device ID: 00382830049702
• NIH Device Record Key: e215f5c5-7634-4ae9-8636-a278bc7e92e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clavis
• Version Model Number: 9015A0012
• Catalog Number: 9015A0012
• 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: false
• Serial Number: true
• 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	00382830049702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062478

FDA Product Code

• GWL: Amplifier, Physiological Signal

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: 2019-03-20
• Device Publish Date: 2019-03-12

Devices Manufactured by NATUS MANUFACTURING LIMITED

• 00382830051156 - Grass® MR Conditional/CT Cup Electrodes: 2024-09-18 Grass® MR Conditional/CT Cup Electrodes Single, 1-12, 12/pkg, 1M
• 00382830051163 - Grass® MR Conditional/CT Cup Electrodes: 2024-09-18 Grass® MR Conditional/CT Cup Electrodes Single, 1-12, 12/pkg, 1.5M
• 00382830051170 - Grass® MR Conditional/CT Cup Electrodes: 2024-09-18 Grass® MR Conditional/CT Cup Electrodes Single, 13-24, 12/pkg, 1M
• 00382830051187 - Grass® MR Conditional/CT Cup Electrodes: 2024-09-18 Grass® MR Conditional/CT Cup Electrodes Single, 13-24, 12/pkg, 1.5M
• 00382830051200 - Grass® MR Conditional/CT Cup Electrodes: 2024-09-18 Grass® MR Conditional/CT Cup Electrodes Single, 25-36, 12/pkg, 1M
• 00382830051217 - Grass® MR Conditional/CT Cup Electrodes: 2024-09-18 Grass® MR Conditional/CT Cup Electrodes Single, 25-36, 12/pkg, 1.5M
• 00382830051248 - Grass® MR Conditional/CT Cup Electrodes: 2024-09-18 Grass® MR Conditional/CT Cup Electrodes Array, 27 leads, 3 arrays, 1M
• 00382830051255 - Grass® MR Conditional/CT Cup Electrodes: 2024-09-18 Grass® MR Conditional/CT Cup Electrodes Array, 27 leads, 3 arrays, 1.5M