Duns Number:315492330
Device Description: Barraquer keratoplasty sieve spatula 13.5cm
Catalog Number
60.32.64
Brand Name
Medicon
Version/Model Number
60.32.64
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
-
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
HNQ
Product Code Name
Hook, ophthalmic
Public Device Record Key
922aa16a-a212-4431-adb1-7d046627da02
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
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 | 7911 |
2 | A medical device with a moderate to high risk that requires special controls. | 1064 |