Doc Band® CRANIALHELMET3D

GUDID 00860013026110

Cranial Technologies, Inc.

Cranial orthosis

• Primary Device ID: 00860013026110
• NIH Device Record Key: 481ff4e9-a997-46e4-89ad-1d02975ab780
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Doc Band®
• Version Model Number: CRANIALHELMET3D
• Catalog Number: CRANIALHELMET3D
• Company DUNS: 964647788
• Company Name: Cranial Technologies, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013026110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K244056

FDA Product Code

• MVA: Orthosis, Cranial

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: 2026-03-12
• Device Publish Date: 2026-03-04

On-Brand Devices [Doc Band®]

• B288CRANIALHELMET0: CRANIALHELMET
• 00860013026110: CRANIALHELMET3D
• 00860013026103: CRANIALHELMET