MyCRO Band

GUDID 04064409000012

MyCRO Band w/Lining grey

OTTO BOCK HEALTHCARE

Cranial orthosis

• Primary Device ID: 04064409000012
• NIH Device Record Key: 5fa1011d-60aa-4ba5-9261-f9bb90ca504f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyCRO Band
• Version Model Number: 24H1=1
• Company DUNS: 932133408
• Company Name: OTTO BOCK HEALTHCARE
• 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: false
• 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	04064409000012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201426

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: 2021-04-06
• Device Publish Date: 2021-03-29

On-Brand Devices [MyCRO Band]

• 04064409000104: MyCRO Band w/Lining beige
• 04064409000098: MyCRO Band w/Lining brown
• 04064409000081: MyCRO Band w/Lining black
• 04064409000074: MyCRO Band w/Lining blue
• 04064409000067: MyCRO Band w/Lining green
• 04064409000050: MyCRO Band w/Lining dark red
• 04064409000043: MyCRO Band w/Lining orange
• 04064409000036: MyCRO Band w/Lining pink
• 04064409000029: MyCRO Band w/Lining purple
• 04064409000012: MyCRO Band w/Lining grey