Duns Number:627969264
Device Description: This tubing set is used to evacuate surgical smoke using a wall vacuum source.
Catalog Number
-
Brand Name
Nebulae Smoke Evacuation Tubing Set
Version/Model Number
7-510-60
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"
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
c527acdf-cec8-46cb-8095-ed77c01d1558
Public Version Date
June 27, 2019
Public Version Number
1
DI Record Publish Date
June 19, 2019
Package DI Number
10817183020636
Quantity per Package
10
Contains DI Package
00817183020639
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |