Duns Number:645717646
Device Description: Rongeurs #4 5 1/2"
Catalog Number
711-140
Brand Name
Pomee
Version/Model Number
711-140
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMH
Product Code Name
Forceps, Rongeur, Surgical
Public Device Record Key
594480bf-e269-4411-a6d9-7bc38e66057a
Public Version Date
December 23, 2021
Public Version Number
1
DI Record Publish Date
December 15, 2021
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 | 616 |