| Primary Device ID | 05712714666049 |
| NIH Device Record Key | b3281f13-59f6-4a78-ae9b-df66bb48c615 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro well group culture dish, 9-well |
| Version Model Number | 16604 |
| Catalog Number | 16604 |
| Company DUNS | 308547608 |
| Company Name | Vitrolife A/S |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05712714666049 [Primary] |
| GS1 | 15712714666046 [Package] Package: Card board box [10 Units] In Commercial Distribution |
| MQK | Labware, Assisted Reproduction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-09-21 |
| 05712714000041 - EmbryoSlide+ ic8 dish | 2022-08-29 The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for |
| 05712714675317 - KIDScore D3 | 2019-12-06 The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by sco |
| 05712714604010 - EmbryoScope+ | 2018-07-06 EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an en |
| 05712714663505 - EmbryoSlide culture dish | 2018-07-06 The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only |
| 05712714664502 - EmbryoSlide+ culture dish | 2018-07-06 The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reserv |
| 05712714666049 - Micro well group culture dish, 9-well | 2018-07-06The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The nine (9) microwells are intended for embryo culture at al |
| 05712714666049 - Micro well group culture dish, 9-well | 2018-07-06 The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The nine (9) microwells are intended fo |
| 05712714666063 - Micro well group culture dish, 16-well | 2018-07-06 The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intende |
| 05712714603013 - EmbryoScope time-lapse incubator | 2018-03-29 The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for |