Duns Number:080380106
Device Description: 1/4 inch to 7/8 inch adaptor for the Saf-T-Vac Smoke and Fluid Evacuator
Catalog Number
-
Brand Name
Saf-T-Vac Filter Adaptor
Version/Model Number
STV1478
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 11, 2018
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"
Yes
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
-
Product Code
GAZ
Product Code Name
Tubing, Noninvasive
Public Device Record Key
948ee0e1-b27a-4c6f-8949-f555728d79c9
Public Version Date
January 11, 2019
Public Version Number
1
DI Record Publish Date
December 11, 2018
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. | 209 |