Duns Number:308547608
Device Description: EmbryoScope+ consists of the following devices with the following indications for use:The
Catalog Number
16401
Brand Name
EmbryoScope+
Version/Model Number
ES-P1
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
-
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
K173264
Product Code
MQG
Product Code Name
Accessory, Assisted Reproduction
Public Device Record Key
f0bd1999-a8f2-4f62-a7ea-792f8d5f23ac
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |