| Primary Device ID | 00819398027830 |
| NIH Device Record Key | 2b1588dd-3a49-4ac8-a440-87f6a03a22f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClikSeal™ |
| Version Model Number | PC4064200S |
| Catalog Number | PC4064200S |
| Company DUNS | 039981550 |
| Company Name | HARDY DIAGNOSTICS |
| Device Count | 200 |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819398027830 [Unit of Use] |
| GS1 | 00819398027847 [Primary] |
| FMH | Container, Specimen, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-20 |
| Device Publish Date | 2023-03-10 |
| 00819398027830 | ClikSeal Specimen Container, Sterile inside, 120ml, bulk 200/case |
| 00819398027816 | ClikSeal Specimen Container, Non Sterile, 120ml, bulk 200/case |
| 00819398020954 | ClikSeal Specimen Container, Sterile inside, 90ml, bulk 400/case |
| 00816576029020 | ClikSeal Specimen Container, Non Sterile, 90ml, bulk 200/case |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CLIKSEAL 86611929 4884738 Live/Registered |
INTEPLAST GROUP CORPORATION 2015-04-28 |