Duns Number:040729840
Device Description: STEVENS SIEGERT TENOTOMY SCISSORS CURVED DOUBLE BEVELED TUNGSTEN CARBIDE POINTED BLADES PO STEVENS SIEGERT TENOTOMY SCISSORS CURVED DOUBLE BEVELED TUNGSTEN CARBIDE POINTED BLADES POWER CUT GOLD/BLACK
Catalog Number
2400-367
Brand Name
STEVENS SIEGERT TENOTOMY SCISSORS
Version/Model Number
2400-367
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
HRR
Product Code Name
SCISSORS, ORTHOPEDIC, SURGICAL
Public Device Record Key
dbf902c6-3633-4d66-9c7d-7ccf30bff66c
Public Version Date
November 05, 2018
Public Version Number
1
DI Record Publish Date
October 03, 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 |