Duns Number:690680533
Catalog Number
-
Brand Name
1-Day Flat Pack Trial9 BC840
Version/Model Number
+2.00
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LPL
Product Code Name
Lenses, Soft Contact, Daily Wear
Public Device Record Key
df4aa903-0d55-4a2c-8ef6-c67e1a2c7688
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2017
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. | 3853 |
3 | A medical device with high risk that requires premarket approval | 2 |