Duns Number:316625425
Device Description: Swyng ® non-stick bipolar forceps, single-use, US 24 cm SL, bayonet, tip 1,0 x Swyng ® non-stick bipolar forceps, single-use, US 24 cm SL, bayonet, tip 1,0 x 6 mm
Catalog Number
7844405SL
Brand Name
Sutter
Version/Model Number
7844405SL
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
05bb77d5-119a-4a12-afac-9cad3d15aea0
Public Version Date
July 25, 2022
Public Version Number
2
DI Record Publish Date
May 14, 2021
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 |