Duns Number:097824130
Catalog Number
BRT-1034-B
Brand Name
BRT V2 Bent, Cap Pl, 0.3, 0.7 Blue
Version/Model Number
BRT-1034-B
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
-
Product Code
HMX
Product Code Name
Cannula, Ophthalmic
Public Device Record Key
49bbe28e-357e-4002-ab66-212d273bd8c9
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
February 06, 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 | 327 |
2 | A medical device with a moderate to high risk that requires special controls. | 535 |