| Primary Device ID | G031806SQRRL0 |
| NIH Device Record Key | c6d4c53c-afd9-4ebb-bd22-22a66dd4139d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gonad Shield w/ QR Buckle |
| Version Model Number | 806SQRRL |
| Company DUNS | 009647322 |
| Company Name | Shielding International Inc. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G031806SQRRL0 [Primary] |
| IWT | Shield, Gonadal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-20 |
| Device Publish Date | 2023-10-12 |
| G031WABRX2XFLF0 - Wrap Around Back Relief Apron - BRX Belt | 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female-Lead Free: 0.5mm Front / 1.0mm @ overlap / 0.25mm Back (LF) |
| G031WABRX2XFLFL0 - Wrap Around Back Relief Apron - BRX Belt | 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female- Lead Free: 0.35mm- Front / 0.7mm @ overlap / 0.25mm Back (LFL) |
| G031WABRX2XFNL0 - Wrap Around Back Relief Apron - BRX Belt | 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female-Non Lead: 0.5mm Front / 1.0mm @ overlap / 0.25mm Back (NL) |
| G031WABRX2XFNLL0 - Wrap Around Back Relief Apron - BRX Belt | 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female- Non Lead: 0.35mm Front / 0.7mm @ overlap / 0.25mm Back (NLL) |
| G031WABRX2XFRL0 - Wrap Around Back Relief Apron - BRX Belt | 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female- Regular Lead: 0.5mm Front / 1.0mm Overlap / 0.3mm Back (RL) |
| G031WABRX2XFRLL0 - Wrap Around Back Relief Apron - BRX Belt | 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female- Regular Lead: 0.35mm Front / 0.7mm @ Overlap / 0.25mm Back (RLL) |
| G031WABRX2XFTL0 - Wrap Around Back Relief Apron - BRX Belt | 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female-TL Lite Ply: 0.5mm Front / 1.0mm @ overlap / 0.25mm Back (TL) |
| G031WABRX2XFTLL0 - Wrap Around Back Relief Apron - BRX Belt | 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female-TL Lite Ply: 0.35mm Front / 0.7mm @ overlap / 0.25mm Back (TLL) |