Duns Number:791221265
Device Description: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 24
Catalog Number
7013-5710
Brand Name
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 24
Version/Model Number
7013-5710
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
Yes
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
K033089,K033089
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
1b9c47eb-2c0b-473f-9bf2-bfc96790e930
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 02, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |