Duns Number:007198742
Catalog Number
-
Brand Name
Flexible Cystoscopic Biopsy Forceps Double-Action, Stem Only 10 Fr, (
Version/Model Number
331S10
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"
-
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
KOA
Product Code Name
SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
Public Device Record Key
aa1194c5-cee3-4153-b2b9-32dc0cd5581a
Public Version Date
October 12, 2018
Public Version Number
1
DI Record Publish Date
September 11, 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 | 899 |
2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
3 | A medical device with high risk that requires premarket approval | 9 |
U | Unclassified | 4 |