Duns Number:876570990
Device Description: Westcott tenotomy scissors - right, 4 1/2", curved 19mm blades with blunt tips, flat handl Westcott tenotomy scissors - right, 4 1/2", curved 19mm blades with blunt tips, flat handle
Catalog Number
-
Brand Name
Medetz Surgical Instruments
Version/Model Number
11-2219r
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
HNR
Product Code Name
Forceps, Ophthalmic
Public Device Record Key
36551c2d-d5a2-4032-8a1c-d4e02c27a833
Public Version Date
February 18, 2022
Public Version Number
1
DI Record Publish Date
February 10, 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 |