| Primary Device ID | 00620974003434 |
| NIH Device Record Key | d5c5602b-8481-47cb-a567-0628c7584ac2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EcoZyme Ultra |
| Version Model Number | 18560-04 |
| Catalog Number | 18560-04 |
| Company DUNS | 246848147 |
| Company Name | Southmedic Incorporated |
| Device Count | 4 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Size Text, specify | 0 |
| Total Volume | 4 Gallon |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00620974003434 [Unit of Use] |
| GS1 | 10620974003431 [Primary] |
| FLG | Cleaner, ultrasonic, medical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-07 |
| Device Publish Date | 2022-08-30 |
| 00620974003465 | EcoZyme Ultra Enzymatic Detergent 2.5G |
| 00620974003434 | EcoZyme Ultra Enzymatic Detergent 1G |
| 00620974003458 | EcoZyme Ultra Enzymatic Detergent 15G |
| 00620974003441 | EcoZyme Ultra Enzymatic Detergent 5G |