Duns Number:121225812
Catalog Number
-
Brand Name
SourceMark
Version/Model Number
M1018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTQ
Product Code Name
Airway, Nasopharyngeal
Public Device Record Key
472140cc-fcf2-4350-8c3c-390b493d267b
Public Version Date
July 09, 2020
Public Version Number
5
DI Record Publish Date
August 26, 2016
Package DI Number
10897392004214
Quantity per Package
10
Contains DI Package
00897392001957
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 | 24 |
2 | A medical device with a moderate to high risk that requires special controls. | 71 |