Duns Number:341325716
Device Description: Provides a connection between the microkeratome head and the vacuum (or suction) pump. The Provides a connection between the microkeratome head and the vacuum (or suction) pump. The function of the tubing is to provide a conduit for suction to the eye during lamellar surgery.
Catalog Number
5070063
Brand Name
MICROKERATOME Disposable Tubing
Version/Model Number
1
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
HNO
Product Code Name
Keratome, Ac-Powered
Public Device Record Key
65285606-680c-4f1b-a474-acec5b418029
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |