Duns Number:407522184
Device Description: Backflush Needle with tapered tip from 23 gauge/0.6 mm to 27 gauge/0.4 mm and luer lock co Backflush Needle with tapered tip from 23 gauge/0.6 mm to 27 gauge/0.4 mm and luer lock connector for use with 1281.C handpiece.
Catalog Number
1281.CD27
Brand Name
Backflush Needle with tapered tip from 23 gauge/0.6 mm to 27 gauge/0.4 mm
Version/Model Number
1281.CD27
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
-
Product Code
HMX
Product Code Name
Cannula, Ophthalmic
Public Device Record Key
19738bbe-4d47-4047-8be9-40c9c9b95c05
Public Version Date
February 22, 2021
Public Version Number
2
DI Record Publish Date
February 02, 2021
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 | 203 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 149 |