| Primary Device ID | 10816611026059 |
| NIH Device Record Key | 28028b64-a72e-43f1-b999-d787a43d3485 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Halyard Scatter Radiation Shields |
| Version Model Number | 48986 Multi-Purpose Shield W/ FEN L1 |
| Company DUNS | 144884467 |
| Company Name | ANGIOSYSTEMS, INCORPORATED |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816611026052 [Primary] |
| GS1 | 10816611026059 [Package] Contains: 00816611026052 Package: CASE [45 Units] In Commercial Distribution |
| KPY | Shield, Protective, Personnel |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-07 |
| Device Publish Date | 2025-01-30 |
| 10816611026356 | 49079 Peripheral Shield Drape L2 NS |
| 10816611026349 | 49077 Biliary Shield Drape L2 NS |
| 10816611026332 | 49075 Jugular Shield Drape L2 NS |
| 10816611026325 | 49073 Subclavian Shield Drape L2 NS |
| 10816611026318 | 49071 Angiography Shield Drape L2 NS |
| 10816611026301 | 49069 Biopsy Shield Drape L2 NS |
| 10816611026295 | 49038 Multi-Purpose Shield Drape W/ FEN L2 NS |
| 10816611026288 | 49036 Multi-Purpose Shield Drape L2 NS |
| 10816611026271 | 49021 Peripheral Shield Drape L1 NS |
| 10816611026264 | 49017 Biliary Shield Drape L1 NS |
| 10816611026257 | 49000 Jugular Shield Drape L1 NS |
| 10816611026240 | 48989 Subclavian Shield Drape L1 NS |
| 10816611026233 | 48987 Angiography Shield Drape L1 NS |
| 10816611026226 | 48959 Multi-Purpose Shield W/ FEN L1 NS |
| 10816611026219 | 48957 Multi Purpose Shield L1 NS |
| 10816611026189 | 49080 Peripheral Shield Drape L2 |
| 10816611026172 | 49078 Biliary Shield Drape L2 |
| 10816611026165 | 49076 Jugular Shield Drape L2 |
| 10816611026158 | 49074 Subclavian Shield Drape L2 |
| 10816611026141 | 49072 Angiography Shield Drape L2 |
| 10816611026134 | 49070 Biopsy Shield Drape L2 |
| 10816611026127 | 49039 Multi-Purpose Shield Drape W/ FEN L2 |
| 10816611026110 | 49037 Multi-Purpose Shield Drape L2 |
| 10816611026103 | 49035 Peripheral Shield Drape L1 |
| 00816611026090 | 49020 Biliary Shield Drape L1 |
| 10816611026080 | 49016 Jugular Shield Drape L1 |
| 10816611026073 | 48990 Subclavian Shield Drape L1 |
| 10816611026066 | 48988 Angiography Shield Drape L1 |
| 10816611026059 | 48986 Multi-Purpose Shield W/ FEN L1 |
| 00816611026045 | 48958 Multi Purpose Shield L1 |