| Primary Device ID | 00810180841528 |
| NIH Device Record Key | 31e581ca-cb18-4fe5-bece-73b66bee58ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LabChoice Urine Containers with Temperature Strip, Sterile, 90 mL |
| Version Model Number | 43027 |
| Company DUNS | 008124539 |
| Company Name | Dynarex Corporation |
| Device Count | 400 |
| 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 | true |
| 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 | 00810180841528 [Unit of Use] |
| GS1 | 00840117329485 [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 | 2025-03-19 |
| Device Publish Date | 2025-03-11 |
| 00840117340718 - Biopsy Punch, Sterile, 3.0 mm Grey | 2025-04-08 STERILE-R |
| 00840117340725 - Biopsy Punches, Sterile, 3.5 mm, Yellow | 2025-04-08 STERILE-R |
| 00840117340732 - Biopsy Punches, Sterile, 4.0 mm, Blue | 2025-04-08 STERILE-R |
| 00840117340862 - Biopsy Punches, Sterile, 5.0 mm, Pink | 2025-04-08 STERILE-R |
| 00840117340879 - Biopsy Punches, Sterile, 6.0 mm, Light Green | 2025-04-08 STERILE-R |
| 00840117340923 - Biopsy Punches, Sterile, 8.0 mm, Purple | 2025-04-08 |
| 00840117340930 - Biopsy Punches, Sterile, Mixed Box | 2025-04-08 Biopsy Punches, Sterile, Mixed Box, 5 each of 2.0 mm, 3.0 mm, 4.0 mm, 5.0 mm, 6.0 mm |
| 00810180841665 - LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-Sterile | 2025-04-07 |