Duns Number:876570990
Device Description: Iris Scissor, Curved Ribbon Type, Small Blade BL 19mm, 3 7/8"
Catalog Number
-
Brand Name
Iris Scissors
Version/Model Number
11-3397
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
HNF
Product Code Name
Scissors, Ophthalmic
Public Device Record Key
49fdacda-f7d9-40a7-b617-f9d8b337e652
Public Version Date
April 18, 2022
Public Version Number
1
DI Record Publish Date
April 08, 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 | 120 |