Steradian Shield SS0300
GUDID 00853714008103
Radiation Protection Shield
RADUX DEVICES, LLC
Patient radiation shielding pad/drape, single-use| Primary Device ID | 00853714008103 |
| NIH Device Record Key | abfa7573-4d75-4355-b307-e9b252b0dfa8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Steradian Shield |
| Version Model Number | SS0300 |
| Catalog Number | SS0300 |
| Company DUNS | 079668796 |
| Company Name | RADUX DEVICES, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com | |
| Phone | 800-935-3137 |
| hillari.jacobs@raduxdevices.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853714008103 [Primary] |
FDA Product Code
| KPY | Shield, Protective, Personnel |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-24 |
| Device Publish Date | 2025-07-16 |
On-Brand Devices [Steradian Shield]
| 10853714008032 | Radiation Protection Shield |
| 10853714008087 | Radiation Protection Shield |
| 00853714008103 | Radiation Protection Shield |
Trademark Results [Steradian Shield]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERADIAN SHIELD 88369642 not registered Live/Pending |
Radux Devices, LLC 2019-04-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.