Duns Number:040729840
Device Description: STEVENS TENOTOMY SCISSORS SHARP STRAIGHT TUNGSTEN CARBIDE BLADE POWER CUT GOLD/BLACK
Catalog Number
1200-490
Brand Name
STEVENS TENOTOMY SCISSORS
Version/Model Number
1200-490
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
c17136f1-0f83-40c5-8125-d7a1b21549d5
Public Version Date
December 24, 2018
Public Version Number
1
DI Record Publish Date
November 22, 2018
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |