Doc Band® CRANIALHELMET

GUDID B288CRANIALHELMET0

CRANIAL TECHNOLOGIES, INC.

Cranial orthosis Cranial orthosis

• Primary Device ID: B288CRANIALHELMET0
• NIH Device Record Key: 658b8b1b-60bc-4dfb-93cb-ffaf05be9f8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Doc Band®
• Version Model Number: CRANIALHELMET
• Catalog Number: CRANIALHELMET
• 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: false
• 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
HIBCC	B288CRANIALHELMET0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN980001

FDA Product Code

• MVA: Orthosis, Cranial

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: 2016-09-23