| Primary Device ID | 38053326000721 |
| NIH Device Record Key | 498a9e24-68c6-4dd0-92f1-723f529db91f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inoculation Loops |
| Version Model Number | 8175CS20H |
| Catalog Number | 8175CS20H |
| Company DUNS | 428981112 |
| Company Name | COPAN ITALIA SPA |
| Device Count | 50 |
| 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 | 18053326000727 [Unit of Use] |
| GS1 | 28053326000724 [Primary] |
| GS1 | 38053326000721 [Package] Contains: 28053326000724 Package: [4 Units] In Commercial Distribution |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-25 |
| Device Publish Date | 2024-01-17 |
| 38053326004323 | HARD LOOP 10 µL STERILE, IN RESEALABLE BAGS OF 40 PCS |
| 38053326004262 | STERILE HARD 1 µL LOOPS IN RESEALABLE BAG OF 40 PCS |
| 38053326001186 | SOFT LOOP 10 µL STERILE, IN RESEALABLE BAGS OF 40 PCS |
| 38053326001179 | SOFT LOOPS 1 UL STERILE, IN BAG OF 20 PCS |
| 38053326001155 | SOFT LOOPS 1 µL STERILE IN RESEABLE BAG 40 PCS PACKED |
| 38053326000738 | HARD LOOP 10 µL STERILE, IN BAGS OF 20 PCS |
| 38053326000721 | HARD LOOP 1 µL STERILE, IN BAGS OF 20 PCS |
| 38053326000660 | SOFT LOOP 10 µL STERILE, IN BAG OF 20 PCS |
| 38053326000653 | SOFT LOOP 10 UL STERILE, IN BAG OF 10 PCS |