Identity
- Trade Name
- MyCRO Band FDA UDI
- Generic Name
- Cranial orthosis FDA UDI
- Device Name
- MyCRO Band w/Lining orange FDA UDI
- Model / Reference
- 24H1=13 FDA UDI
- Description
- MyCRO Band w/Lining orange FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04064409000043 FDA UDI
- 510(k) Number
- K201426 FDA UDI
- FDA Product Code
- MVA FDA UDIOAN FDA UDI
- GMDN Term
- Cranial orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5970 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cranial orthosis
MyCRO Band by Otto Bock Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cranial orthosis.
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- STARband® Plus — ORTHOMERICA PRODUCTS, INC. · Class II
- STARband® Bi-Valve — ORTHOMERICA PRODUCTS, INC. · Class II
- STARlight® PRO — ORTHOMERICA PRODUCTS, INC. · Class II
- STARlight® PRO — ORTHOMERICA PRODUCTS, INC. · Class II
- STARband® Plus — ORTHOMERICA PRODUCTS, INC. · Class II
Cleared under the same submission
K201426 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Otto Bock Healthcare
Sources (1)
- FDA UDI 51fcaab5-5abe-4b69-8285-087bf183e01d 34 fields · synced May 30, 2026