Cotton Bite Block

GUDID 10850045508071

MECTA ECT Cotton Bite Blocks Size Large

SIGMASTIM DOMESTIC, LLC

Seizure bite block

• Primary Device ID: 10850045508071
• NIH Device Record Key: 03e926fe-9627-4e48-91ba-7b827fa9fc0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cotton Bite Block
• Version Model Number: 9391-0003 L
• Company DUNS: 111226730
• Company Name: SIGMASTIM DOMESTIC, LLC
• 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: 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	10850045508071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201309

FDA Product Code

• JXL: Block, Bite

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: 2025-02-04
• Device Publish Date: 2025-01-27

On-Brand Devices [Cotton Bite Block]

• 10850045508088: MECTA ECT Cotton Bite Blocks Size Medium
• 10850045508071: MECTA ECT Cotton Bite Blocks Size Large