| Primary Device ID | 00814105021224 |
| NIH Device Record Key | 35b75f6f-87dd-4913-94b0-14d6b37f185e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACU-SABOURAUD |
| Version Model Number | M103 |
| Company DUNS | 071426803 |
| Company Name | ACUDERM, INC. |
| Device Count | 24 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814105021224 [Unit of Use] |
| GS1 | 10814105021221 [Primary] |
| JSJ | Culture Media, Selective And Non-Differential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-30 |
| Device Publish Date | 2020-09-22 |
| 00814105020005 - Acu-Dispo-Curette | 2020-09-30 Acu-Dispo-Curette 1mm cup |
| 00814105020012 - Acu-Dispo-Curette | 2020-09-30 Acu-Dispo-Curette 2mm, Single |
| 00814105020029 - Acu-Dispo-Curette | 2020-09-30 Acu-Dispo-Curette 3mm, Single |
| 00814105020036 - Acu-Dispo-Curette | 2020-09-30 Acu-Dispo-Curette 4mm, Single |
| 00814105020043 - Acu-Dispo-Curette | 2020-09-30 Acu-Dispo-Curette 5mm, Single |
| 00814105020050 - Acu-Dispo-Curette | 2020-09-30 Acu-Dispo-Curette 7mm, Single |
| 00814105020883 - Acu-Punch | 2020-09-30 Acu-Punch, 1mm, 1ea |
| 00814105020890 - Acu-Punch | 2020-09-30 Acu-Punch, 1.5mm, Single |