Duns Number:645717646
Device Description: McCalls Curette
Catalog Number
711-751
Brand Name
Pomee
Version/Model Number
711-751
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
EMS
Product Code Name
Curette, Periodontic
Public Device Record Key
b7a8bd79-5f96-48d5-a49c-dd6677b64b3a
Public Version Date
January 11, 2022
Public Version Number
1
DI Record Publish Date
January 03, 2022
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 |