Duns Number:007198742
Catalog Number
-
Brand Name
REPLACEMENT RICHARDS ADAPTOR
Version/Model Number
230883
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 2020
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
K932988
Product Code
EOB
Product Code Name
NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
b0a8d049-754d-4695-93c8-1ce32ac9dbb2
Public Version Date
October 06, 2022
Public Version Number
4
DI Record Publish Date
May 09, 2017
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 | 899 |
2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
3 | A medical device with high risk that requires premarket approval | 9 |
U | Unclassified | 4 |