Duns Number:013469890
Device Description: MICROKERATOME Tubing Set. Disposable and have proper keratome fittings with a moisture tra MICROKERATOME Tubing Set. Disposable and have proper keratome fittings with a moisture trap. A precision filter captures the mositure before it can cause damage to your microkeratome console. Sterile. Compatible ACS, ALK & Hansatome Systems, 5/box.
Catalog Number
MK-T102
Brand Name
NA
Version/Model Number
MK-T102
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
GAZ
Product Code Name
Tubing, Noninvasive
Public Device Record Key
75c25282-8f63-49b5-9ec0-ab636c5cdefc
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 30, 2018
Package DI Number
30810003220128
Quantity per Package
5
Contains DI Package
10810003220124
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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 5 |