Duns Number:711789789
Catalog Number
-
Brand Name
Single Use Grasping Forceps
Version/Model Number
FG-220P
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200342,K200342
Product Code
EOB
Product Code Name
Nasopharyngoscope (flexible or rigid)
Public Device Record Key
193760f4-5da1-4150-8d8a-b7cf6843ed58
Public Version Date
July 01, 2021
Public Version Number
1
DI Record Publish Date
June 23, 2021
Package DI Number
14953170435857
Quantity per Package
1
Contains DI Package
04953170435850
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |