Duns Number:101740835
Catalog Number
-
Brand Name
FOLLISTIM AQ Cartridge 600IU SAMPLE
Version/Model Number
1746814
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
918deb42-ecdb-4544-a5c1-a318b97a09ed
Public Version Date
November 05, 2019
Public Version Number
1
DI Record Publish Date
October 28, 2019
Package DI Number
60300520316813
Quantity per Package
10
Contains DI Package
00300520316811
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |