Duns Number:016889401
Device Description: Starvac Coblation Wand; 5.5mm tip; 90 deg; w/suction
Catalog Number
STASC4251-01
Brand Name
Sustainable Technologies
Version/Model Number
STASC4251-01
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
K173741,K173741,K173741
Product Code
NUJ
Product Code Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Public Device Record Key
21268642-08a4-4463-a514-93864133b732
Public Version Date
May 24, 2021
Public Version Number
6
DI Record Publish Date
December 12, 2019
Package DI Number
10810041632361
Quantity per Package
1
Contains DI Package
00810041632364
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 | 3993 |
2 | A medical device with a moderate to high risk that requires special controls. | 1216 |