Duns Number:787855907
Device Description: Open Smoke Evacuation Tubing w/ Wand and Sponge Guard
Catalog Number
OL3MT24
Brand Name
OR-VAC
Version/Model Number
OL3MT24
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2022
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
9500ba95-a1ef-4c6d-883a-e7467f8d780b
Public Version Date
April 22, 2022
Public Version Number
2
DI Record Publish Date
July 12, 2018
Package DI Number
10815198012776
Quantity per Package
24
Contains DI Package
00815198012779
Package Discontinue Date
April 21, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 104 |