| Primary Device ID | 05411967001590 |
| NIH Device Record Key | dfa644db-f9a5-45db-b436-b0fa26758bc8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spermac Stain - Stain B (250ml) |
| Version Model Number | SPS250B |
| Company DUNS | 373904101 |
| Company Name | Fertipro NV |
| 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 | 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 | false |
| Phone | +3250791805 |
| info@fertipro.com |
| Total Volume | 250 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05411967001590 [Primary] |
| LED | Stains, Chemical Solution |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-10 |
| Device Publish Date | 2018-08-22 |
| 54119670015908 | Spermac Stain is a qualitative diagnostic kit for staining human spermatozoa. The purpose of sta |
| 05411967001590 | Spermac Stain is a qualitative diagnostic kit for staining human spermatozoa. The purpose of sta |