| Primary Device ID | 00810053950586 |
| NIH Device Record Key | 09d877bf-ef22-4420-ac37-5d4e852f638d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVEOS Mulberry, Morus alba |
| Version Model Number | T070 |
| Catalog Number | 8633250Z |
| Company DUNS | 010558476 |
| Company Name | HYCOR BIOMEDICAL LLC |
| Device Count | 1 |
| 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 |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810053950586 [Primary] |
| PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-04 |
| Device Publish Date | 2025-08-27 |
| 00816879024500 | T070 |
| 00810053950586 | T070 |