Duns Number:832696038
Device Description: WESTCOTT TENOTOMY SCISSORS RIGHT, SLIGHTLY CURVED BLADES 21MM FROM MID-SCREW,WIDE HNDL OVE WESTCOTT TENOTOMY SCISSORS RIGHT, SLIGHTLY CURVED BLADES 21MM FROM MID-SCREW,WIDE HNDL OVERALL LENGTH 4-1/8"(10.5CM)
Catalog Number
OP5670
Brand Name
V. Mueller
Version/Model Number
OP5670
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
0e2f11a1-5908-4e46-b102-9dce0cc3bbed
Public Version Date
February 04, 2019
Public Version Number
1
DI Record Publish Date
January 02, 2019
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |