V-ONESTEP V-OSM-20P
GUDID 04260650070020
V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
VITROMED GmbH
IVF medium| Primary Device ID | 04260650070020 |
| NIH Device Record Key | 369898ad-52bd-49d9-8547-91e0117f142a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | V-ONESTEP |
| Version Model Number | V-OSM-20P |
| Catalog Number | V-OSM-20P |
| Company DUNS | 315234102 |
| Company Name | VITROMED GmbH |
| Device Count | 1 |
| 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260650070020 [Primary] |
| GS1 | 04260650071720 [Package] Package: Board box [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193285
FDA Product Code
| MQL | Media, Reproductive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-13 |
| Device Publish Date | 2022-04-05 |
On-Brand Devices [V-ONESTEP]
| 04260650070013 | V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages |
| 04260650072437 | V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages |
| 04260650071614 | V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages |
| 04260650070020 | V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages |
Trademark Results [V-ONESTEP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 V-ONESTEP 79278433 not registered Live/Pending |
VITROMED GmbH 2020-01-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.