Duns Number:316625425
Device Description: Swyng ® non-stick bipolar forceps, single-use, US 21 cm ST, bayonet, tip 0,5 x Swyng ® non-stick bipolar forceps, single-use, US 21 cm ST, bayonet, tip 0,5 x 6 mm
Catalog Number
7844105ST
Brand Name
Sutter
Version/Model Number
7844105ST
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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"
Yes
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
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
2a089d49-d943-46fd-b0e9-174c4e94f287
Public Version Date
July 25, 2022
Public Version Number
2
DI Record Publish Date
February 28, 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 265 |