Identity
- Trade Name
- SecureShield© EP 12" x 17" Scatter Reducing Drape FDA UDI
- Generic Name
- Patient radiation shielding pad/drape, single-use FDA UDI
- Device Name
- Excellent protection for device implant procedures such as Bi-V pacing, etc. Specially designed scoop fenestration allows easy access to site and maximum radiation protection. Specifically designed to protect the physician’s hand, body and head. The unique half-moon fenestration is large enough to allow easy access at the entry point, but small enough to block dangerous scatter radiation. FDA UDI
- Model / Reference
- SS-5400 FDA UDI
- Description
- Excellent protection for device implant procedures such as Bi-V pacing, etc. Specially designed scoop fenestration allows easy access to site and maximum radiation protection. Specifically designed to protect the physician’s hand, body and head. The unique half-moon fenestration is large enough to allow easy access at the entry point, but small enough to block dangerous scatter radiation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10860004894657 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Patient radiation shielding pad/drape, single-use 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
Yes
FDA UDI
Single Use
Yes
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: Patient radiation shielding pad/drape, single-use
SecureShield© EP 12" x 17" Scatter Reducing Drape by Barrier Technologies, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient radiation shielding pad/drape, single-use.
- Halyard Scatter Radiation Shields — ANGIOSYSTEMS, INCORPORATED · Class I
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class II
- AngioSystems SorbX — ANGIOSYSTEMS, INCORPORATED · Class I
- Halyard Scatter Radiation Shields — ANGIOSYSTEMS, INCORPORATED · Class I
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class II
- UniRay — UNIRAY MEDICAL LLP · Class I
- Halyard Scatter Radiation Shields — ANGIOSYSTEMS, INCORPORATED · Class I
- Halyard Scatter Radiation Shields — ANGIOSYSTEMS, INCORPORATED · 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 |
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Manufacturer
- Manufacturer
- Barrier Technologies, Llc
Sources (1)
- FDA UDI 16480248-d2b9-449d-89a4-449a43a094ea 33 fields · synced Jun 6, 2026