Duns Number:506826739
Device Description: Operating scissors 11.5 cm "Iris"SUPER CUT curvedF-LINE SC
Catalog Number
-
Brand Name
devemed
Version/Model Number
1156-11 F
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
EGN
Product Code Name
Scissors, Surgical Tissue, Dental
Public Device Record Key
c76b39fb-b522-470a-b724-2c02ff9a5e15
Public Version Date
April 14, 2020
Public Version Number
1
DI Record Publish Date
April 06, 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 | 2521 |