Duns Number:071595540
Device Description: Smoke Evacuation Tubing 1-3/8 in (35mm) x 6 ft (1.8m) tube with wand & sponge guard
Catalog Number
VTWT505
Brand Name
Buffalo Filter
Version/Model Number
VTWT505
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
-
Product Code
GAZ
Product Code Name
TUBING, NONINVASIVE
Public Device Record Key
1bc52708-16c6-4811-8c27-ea6a068d8642
Public Version Date
April 22, 2022
Public Version Number
2
DI Record Publish Date
June 01, 2020
Package DI Number
30845854080904
Quantity per Package
5
Contains DI Package
20845854080907
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |