Duns Number:075390489
Device Description: Disposable Tubing for use with the ML7 Microkeratome
Catalog Number
ML8060VS
Brand Name
Vacuum Tubing
Version/Model Number
ML8060VS
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
KYG
Product Code Name
Device, Irrigation, Ocular Surgery
Public Device Record Key
03b98299-8716-4cf6-bb25-989229dc654b
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
August 27, 2020
Package DI Number
10850724001206
Quantity per Package
10
Contains DI Package
00850724001209
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 32 |