Duns Number:318268125
Device Description: Forceps upper incisors and canines, broad, fig.1, Fifo
Catalog Number
801.00
Brand Name
STOMA®
Version/Model Number
801.00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMG
Product Code Name
FORCEPS, TOOTH EXTRACTOR, SURGICAL
Public Device Record Key
429b112b-3e66-4042-8d16-e5a7295a80e6
Public Version Date
September 04, 2020
Public Version Number
1
DI Record Publish Date
August 27, 2020
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 | 1204 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |