Duns Number:024328124
Device Description: Disposable Bipolar Cord Straight 12 FT
Catalog Number
-
Brand Name
STINGRAY SURGICAL PRODUCTS
Version/Model Number
S04-800
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
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
dd82351d-cef1-4ebf-a0eb-01267a680a39
Public Version Date
May 08, 2018
Public Version Number
3
DI Record Publish Date
June 06, 2017
Package DI Number
B112S048001
Quantity per Package
10
Contains DI Package
B112S048000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 133 |
2 | A medical device with a moderate to high risk that requires special controls. | 4643 |