Duns Number:809555139
Device Description: Westcott Tenotomy Scissors, Curved for right handed use, Blunt tips Standard Blades, 21mm Westcott Tenotomy Scissors, Curved for right handed use, Blunt tips Standard Blades, 21mm from pivot to tip, Serrated Scissor-Action Handle, 117mm total length, Stainless
Catalog Number
S502-CR
Brand Name
Diamatrix Ltd
Version/Model Number
S502-CR
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
HNF
Product Code Name
Scissors, Ophthalmic
Public Device Record Key
4271d64e-f6c8-4421-8847-d315e8a2db4d
Public Version Date
December 15, 2020
Public Version Number
1
DI Record Publish Date
December 07, 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 | 475 |
| U | Unclassified | 13 |