Duns Number:752103403
Device Description: The Geri Dish is intended to be used for preparation, storage and imaging of human embryos The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.
Catalog Number
-
Brand Name
Geri Dish
Version/Model Number
GERI-DSH-20
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171736,K171736,K171736
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
3930cb5b-742b-4afa-8ab8-bdc7d23f9290
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
December 08, 2017
Package DI Number
29348265003011
Quantity per Package
24
Contains DI Package
19348265003014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |