Duns Number:879324241
Device Description: MEMBRANE SPATULA HOOKED 20G
Catalog Number
-
Brand Name
Opthalmic Spatula
Version/Model Number
OI-2282T-20G
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
HND
Product Code Name
Spatula, Ophthalmic
Public Device Record Key
3b56ec0f-41f8-43cd-a640-218e1675d3a2
Public Version Date
January 31, 2022
Public Version Number
1
DI Record Publish Date
January 21, 2022
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 | 161 |