Identity
- Trade Name
- Cap FDA UDI
- Generic Name
- Radiation shielding head wear FDA UDI
- Device Name
- Cap - Standard Size with Tie Closure .35mm Burlite Size Medium FDA UDI
- Model / Reference
- SBCAP1M FDA UDI
- Description
- Cap - Standard Size with Tie Closure .35mm Burlite Size Medium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840186610187 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
Cap 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Burlington Medical, Llc
Sources (1)
- FDA UDI 5de6abc1-8d29-404d-a495-c72f46a90055 34 fields · synced Jun 6, 2026