Identity
- Trade Name
- Boston Band FDA UDI
- Generic Name
- Cranial orthosis FDA UDI
- Device Name
- Boston Band custom cranial remolding orthosis FDA UDI
- Model / Reference
- BB1 FDA UDI
- Description
- Boston Band custom cranial remolding orthosis FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010708101 FDA UDI
- 510(k) Number
- K111609 FDA UDI
- FDA Product Code
- MVA 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
MR Unsafe FDA UDI
Category: Cranial orthosis
Boston Band by Boston Brace International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Boston Brace International, Inc.
Sources (1)
- FDA UDI 97f906f8-e5cd-4558-892f-8f3bcb71c9c0 35 fields · synced May 30, 2026