Identity
- Trade Name
- SCOLIOSISSTOLE FDA UDI
- Generic Name
- Radiation shielding head wear FDA UDI
- Device Name
- RCCSS-OS (SCOLIOSIS STOLE, .5MM COST CRUNCHER, SCOLIOSIS STOLE, ADULT OS) FDA UDI
- Model / Reference
- RCCSS-OS FDA UDI
- Description
- RCCSS-OS (SCOLIOSIS STOLE, .5MM COST CRUNCHER, SCOLIOSIS STOLE, ADULT OS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840331276169 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Radiation shielding head wear FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation shielding head wear
Scoliosisstole by Burlington Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation shielding head wear.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Burlington Medical, Llc
Sources (1)
- FDA UDI af38eb16-3544-4789-8cec-606d9d71ff8c 33 fields · synced Jun 8, 2026