| Primary Device ID | 58053326009797 |
| NIH Device Record Key | 5d07d19a-5fbc-4445-b899-fa8dc6f0cdee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLASSIQSwabs™ |
| Version Model Number | 1U054S01.US |
| Company DUNS | 428981112 |
| Company Name | COPAN ITALIA SPA |
| Device Count | 100 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18053326009799 [Unit of Use] |
| GS1 | 38053326009793 [Primary] |
| GS1 | 58053326009797 [Package] Contains: 38053326009793 Package: [10 Units] In Commercial Distribution |
| KXG | Applicator, Absorbent Tipped, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-07 |
| Device Publish Date | 2024-04-29 |
| 18053326005685 | STERILE PLASTIC APPLICATOR RAYON TIPPED INDIVIDUALLY WRAPPED |
| 18053326005579 | STERILE PLASTIC APPLICATOR POLYESTER TIPPED INDIVIDUALLY WRAPPED |
| 58053326009636 | Regular Polyester Swab, marked breaking point 73mm |
| 58053326008493 | Regular Polyester Swab, breaking point 100mm |
| 58053326005768 | STERILE ALUMINIUM APPLICATOR DACRON TIPPED INDIVIDUALLY WRAPPED |
| 58053326005744 | ALUMINIUM APPLICATOR RAYON TIPPED STERILE IND. WRAPPED |
| 58053326005522 | "PLASTIC SWAB BP 33MM STERILE IND.WRAPPED " |
| 28053326004906 | PLAIN SWAB STERILE SOFT ALUMINIUM APPLICATOR |
| 28053326004685 | PLAIN SWAB STERILE PLASTIC APPLICATOR POLYESTER TIPPED |
| 28053326000991 | PLAIN SWAB STERILE ALUMINIUM APPLICATOR POLYESTER TIPPED |
| 28053326000984 | "PLAIN SWAB STERILE ALUMINIUM APPLICATOR RAYON TIPPED " |
| 28053326000632 | PLAIN SWAB STERILE TWISTED APPLICATOR RAYON TIPPED |
| 28053326000625 | PLAIN SWAB STERILE PLASTIC APPLICATOR RAYON TIPPED |
| 38053326001001 | PLAIN DUAL SWAB PLASTIC APPLICATOR RAYON TIPPED IND. WRAPPED |
| 18053326005753 | STERILE ALUMINIUM APPLICATOR DACRON TIPPED INDIVIDUALLY WRAPPED |
| 58053326005782 | Ultra-Thin minitp swab, polyester tip, sterile individually wrapped |
| 58053326005775 | Ultra-Thin minitp swab, rayon tip, sterile individually wrapped |
| 58053326009797 | Regular Polyester Swab, breaking point 100mm |
| 58053326005690 | Sterile Plastic Applicator Rayon Tipped Individually Wrapped |
| 58053326005591 | Sterile Plastic Applicator Poliester Tipped Individually Wrapped |