Duns Number:809555139
Device Description: Bimanual Aspirating Unit, 23g Cannula Tip with Titanium Aspirating Handle, Curved .3mm Sin Bimanual Aspirating Unit, 23g Cannula Tip with Titanium Aspirating Handle, Curved .3mm Single Port, 111mm Overall Length
Catalog Number
BA152301
Brand Name
Diamatrix Ltd.
Version/Model Number
BA152301
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)
Yes
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
451c81bc-2884-44e1-acf1-674941e40eb2
Public Version Date
May 19, 2022
Public Version Number
1
DI Record Publish Date
May 11, 2022
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 | 475 |
U | Unclassified | 13 |