Duns Number:812762226
Device Description: I/A Co-axial Handpiece Soft Tip Straight Tip
Catalog Number
-
Brand Name
I/A Co-axial Handpiece Soft Tip Straight Tip
Version/Model Number
92-4000
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
32921650-5fcb-4ced-a2e7-199cdc3856c2
Public Version Date
October 07, 2019
Public Version Number
6
DI Record Publish Date
June 29, 2017
Package DI Number
10848782024053
Quantity per Package
5
Contains DI Package
00848782024056
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 300 |
2 | A medical device with a moderate to high risk that requires special controls. | 2030 |
U | Unclassified | 19 |