Duns Number:040729840
Device Description: SONTEC MICRO RASPATORY SINGLE ENDED/SIDED 3 MILLIMETERS X 30 MILLIMETERS X 2 MILLIMETERS E SONTEC MICRO RASPATORY SINGLE ENDED/SIDED 3 MILLIMETERS X 30 MILLIMETERS X 2 MILLIMETERS EXTRA NECK
Catalog Number
345-267
Brand Name
SONTEC MICRO RASPATORY
Version/Model Number
345-267
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
-
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
KBA
Product Code Name
RASP, NASAL
Public Device Record Key
1c17a17f-2f9d-4be6-aa0a-5855ae2aafff
Public Version Date
March 31, 2021
Public Version Number
5
DI Record Publish Date
September 20, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |