Duns Number:055870299
Device Description: Westcott Tenotomy Scissors, Right 11cm, 19mm fm mid-screw to tip, blunt Cvd.
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.22726R
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)
-
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
17185b80-1ad5-4fef-b9d5-aab7df42949f
Public Version Date
September 23, 2022
Public Version Number
2
DI Record Publish Date
June 25, 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 | 1975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 400 |