Duns Number:001406024
Device Description: Punctal Dilator and Probe [Khan] .70mm x 45mm (22G x 1 3/4in)
Catalog Number
-
Brand Name
Visitec®
Version/Model Number
585124
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
HNL
Product Code Name
Probe, Lachrymal
Public Device Record Key
3e9377fa-d96a-4bcb-974b-23e10a752e08
Public Version Date
December 13, 2021
Public Version Number
1
DI Record Publish Date
December 03, 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 | 441 |
2 | A medical device with a moderate to high risk that requires special controls. | 35 |
U | Unclassified | 34 |