Duns Number:152161337
Device Description: This system is intended to be used to drill a small tangential bole in or to thin the zona This system is intended to be used to drill a small tangential bole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as advanced maternal age, prior failed IVF procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in lyE patients undergoing PGD to avoid genetic disease or aneuploidy.
Catalog Number
-
Brand Name
ZILOS-tk™
Version/Model Number
ZILOS-tk
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063636,K120055
Product Code
MRX
Product Code Name
System, Assisted Reproduction Laser
Public Device Record Key
831fd781-c052-4d84-819d-1ab682679274
Public Version Date
December 09, 2019
Public Version Number
1
DI Record Publish Date
November 30, 2019
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |