Duns Number:758568000
Device Description: SYDNEY IVF, SPERM MEDIUM
Catalog Number
K-SISM-100-AA
Brand Name
Sydney IVF
Version/Model Number
G46314
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
K152782
Product Code
MQL
Product Code Name
MEDIA, REPRODUCTIVE
Public Device Record Key
3bcb3417-2bc3-4b77-975a-81b174693bc2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 15, 2016
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. | 106 |
3 | A medical device with high risk that requires premarket approval | 93 |