| Primary Device ID | 00841277110302 |
| NIH Device Record Key | 297de944-bd27-4463-b0f8-eec2cc62d190 |
| Commercial Distribution Discontinuation | 2025-04-28 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Sempermed iconiX bi-fusion |
| Version Model Number | ICNX 104 |
| Catalog Number | ICNX 104 |
| Company DUNS | 004072158 |
| Company Name | SEMPERMED USA, INC. |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841277110258 [Primary] |
| GS1 | 00841277110302 [Unit of Use] |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-06 |
| Device Publish Date | 2025-04-28 |
| 00841277110395 | Sempermed iconiX bi-fusion Nitrile Examination (SAMPLE PACK) |
| 00841277110326 | Sempermed iconiX bi-fusion Nitrile Examination Gloves (XXL) |
| 00841277110319 | Sempermed iconiX bi-fusion Nitrile Examination Gloves (XL) |
| 00841277110302 | Sempermed iconiX bi-fusion Nitrile Examination Gloves (L) |
| 00841277110296 | Sempermed iconiX bi-fusion Nitrile Examination Gloves (M) |
| 00841277110289 | Sempermed iconiX bi-fusion Nitrile Examination Gloves (S) |