Duns Number:040729840
Device Description: OVERSTREET POLYP FORCEPS FENESTRATED JAW
Catalog Number
525-225
Brand Name
OVERSTREET POLYP FORCEPS
Version/Model Number
525-225
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 16, 2020
Issuing Agency
In GS1
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
HFB
Product Code Name
FORCEPS, BIOPSY, GYNECOLOGICAL
Public Device Record Key
30a5b5b4-81c9-477e-80f6-8c55da89174f
Public Version Date
October 19, 2020
Public Version Number
3
DI Record Publish Date
September 14, 2018
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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |