Duns Number:645717646
Device Description: Extracting Forceps # MD 2 universal upper, 1st, 2nd, 3rd Molar
Catalog Number
706-322
Brand Name
Pomee
Version/Model Number
706-322
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
66d34471-97f6-4fe8-8ad5-0b21a460b234
Public Version Date
December 16, 2021
Public Version Number
1
DI Record Publish Date
December 08, 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 |