Duns Number:040729840
Device Description: Antrum Biopsy Forceps 3.0 Millimeters X 5.0 Millimeters Oval Vertical Cup Double Action St Antrum Biopsy Forceps 3.0 Millimeters X 5.0 Millimeters Oval Vertical Cup Double Action Straight Jaw
Catalog Number
-
Brand Name
Antrum Biopsy Forceps
Version/Model Number
468-371
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
KAE
Product Code Name
FORCEPS, ENT
Public Device Record Key
7e363493-4f06-4b05-8466-402f6b6e8897
Public Version Date
July 29, 2021
Public Version Number
1
DI Record Publish Date
July 21, 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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |