Identity
- Trade Name
- ExoShield FDA UDI
- Generic Name
- Radiation shielding panel, fixed FDA UDI
- Device Name
- External lead shielding FDA UDI
- Model / Reference
- 40010548 FDA UDI
- Description
- External lead shielding FDA UDI
Identifiers
- Catalog Number
- 40010548 FDA UDI
- Primary DI / UDI-DI
- 00860002676401 FDA UDI
- FDA Product Code
- EAK FDA UDI
- GMDN Term
- Radiation shielding panel, fixed 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiation shielding panel, fixed
ExoShield by Northstar Medical Radioisotopes, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation shielding panel, fixed.
- Hercules — AADCO MEDICAL, INC. · Class I
- Hercules — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- Corning® Med-Gamma ® Glass — CORNING SAS · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- MRI-Safe — AADCO MEDICAL, INC. · Class I
- Hercules — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
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
- Northstar Medical Radioisotopes, Llc
Sources (1)
- FDA UDI 0ad6aed4-4ae4-4481-8a73-5d3a154443ef 34 fields · synced Jun 6, 2026