Duns Number:808865125
Catalog Number
-
Brand Name
SURGISTAR
Version/Model Number
182307
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
K961524,K961524
Product Code
HMX
Product Code Name
Cannula, Ophthalmic
Public Device Record Key
a7959899-19a7-48e6-9fbb-26598c0a2856
Public Version Date
February 06, 2020
Public Version Number
1
DI Record Publish Date
January 29, 2020
Package DI Number
10878799003185
Quantity per Package
10
Contains DI Package
00878799003188
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 757 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
U | Unclassified | 6 |