Duns Number:645717646
Device Description: Kelly 6 1/4" curved
Catalog Number
762-235
Brand Name
Pomee
Version/Model Number
762-235
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
EGN
Product Code Name
Scissors, Surgical Tissue, Dental
Public Device Record Key
f5217aa7-909c-489b-a9b9-b48cd6d31d6a
Public Version Date
December 27, 2021
Public Version Number
1
DI Record Publish Date
December 18, 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 |