← Back to catalogue
SecureShield© for Dialysis 42" x 32" Scatter Reducing Drape
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- SecureShield© for Dialysis 42" x 32" Scatter Reducing Drape FDA UDI
- Generic Name
- Patient radiation shielding pad/drape, single-use FDA UDI
- Device Name
- Outstanding protection during dialysis declotting procedures. Up to 80+% and 50% exposure reductions at hands and eyes, respectively. Shielding is easily adjustable as needed. Clinically proven to attenuate 95% of a 100kV direct beam. SecureShield Dialysis Access pads provide excellent protection for interventionalists and their teams during DADD procedures. FDA UDI
- Model / Reference
- SS-7200 FDA UDI
- Description
- Outstanding protection during dialysis declotting procedures. Up to 80+% and 50% exposure reductions at hands and eyes, respectively. Shielding is easily adjustable as needed. Clinically proven to attenuate 95% of a 100kV direct beam. SecureShield Dialysis Access pads provide excellent protection for interventionalists and their teams during DADD procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10860004894664 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© for Dialysis 42" x 32" Scatter Reducing Drape by Barrier Technologies, Llc — Class I — FDA UDI — listed in FDA GUDID
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Barrier Technologies, Llc
Sources (1)
- FDA UDI 5237c2c3-7ea4-4383-9e32-5a32f326b669 33 fields · synced Jun 8, 2026