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SecureShield© Angiography 13" x 16" Scatter Reducing Drape
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- SecureShield© Angiography 13" x 16" Scatter Reducing Drape FDA UDI
- Generic Name
- Patient radiation shielding pad/drape, single-use FDA UDI
- Device Name
- Ultimate protection for femoral artery and radial access procedures. Unique shield design protects hands, face and body. Will not inhibit the physicians technique. The small fenestration and the slit to the shield edge provide maximum protection to hands and body and excellent maneuverability around the sheath. FDA UDI
- Model / Reference
- SS-5300 FDA UDI
- Description
- Ultimate protection for femoral artery and radial access procedures. Unique shield design protects hands, face and body. Will not inhibit the physicians technique. The small fenestration and the slit to the shield edge provide maximum protection to hands and body and excellent maneuverability around the sheath. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10860004894640 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© Angiography 13" x 16" 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 1fae5312-897b-4cd7-a984-788f26d950b0 33 fields · synced Jun 8, 2026