Grass® MR Conditional/CT Cup Electrodes

GUDID 00382830051217

Grass® MR Conditional/CT Cup Electrodes Single, 25-36, 12/pkg, 1.5M

NATUS MANUFACTURING LIMITED

Analytical scalp electrode, single-use

• Primary Device ID: 00382830051217
• NIH Device Record Key: ea58081e-dd33-46ca-b5bb-f0bb10077bfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grass® MR Conditional/CT Cup Electrodes
• Version Model Number: MRSIN3-59
• Company DUNS: 896421240
• Company Name: NATUS MANUFACTURING LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00382830051217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242346

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: 2024-09-18
• Device Publish Date: 2024-09-10

On-Brand Devices [Grass® MR Conditional/CT Cup Electrodes ]

• 00382830051347: Grass® MR Conditional/CT Cup Electrodes Array, 30 leads, 4 arrays, 1.5M
• 00382830051330: Grass® MR Conditional/CT Cup Electrodes Array, 30 leads, 4 arrays, 1M
• 00382830051323: Grass® MR Conditional/CT Cup Electrodes Array, 23 leads, 3 arrays, 1.5M
• 00382830051316: Grass® MR Conditional/CT Cup Electrodes Array, 23 leads, 3 arrays, 1M
• 00382830051309: MR Array D/C Electrode 25 Lead w/1.5M ext
• 00382830051293: Grass® MR Conditional/CT Cup Electrodes Array, 25 leads, 3 arrays, 1M
• 00382830051255: Grass® MR Conditional/CT Cup Electrodes Array, 27 leads, 3 arrays, 1.5M
• 00382830051248: Grass® MR Conditional/CT Cup Electrodes Array, 27 leads, 3 arrays, 1M
• 00382830051217: Grass® MR Conditional/CT Cup Electrodes Single, 25-36, 12/pkg, 1.5M
• 00382830051200: Grass® MR Conditional/CT Cup Electrodes Single, 25-36, 12/pkg, 1M
• 00382830051187: Grass® MR Conditional/CT Cup Electrodes Single, 13-24, 12/pkg, 1.5M
• 00382830051170: Grass® MR Conditional/CT Cup Electrodes Single, 13-24, 12/pkg, 1M
• 00382830051163: Grass® MR Conditional/CT Cup Electrodes Single, 1-12, 12/pkg, 1.5M
• 00382830051156: Grass® MR Conditional/CT Cup Electrodes Single, 1-12, 12/pkg, 1M