Duns Number:315018218
Device Description: PERNECZKY/CRISTANTE XS Tumor Forceps, 9", (230 mm), working length: 4", (100 mm), diam. 3 PERNECZKY/CRISTANTE XS Tumor Forceps, 9", (230 mm), working length: 4", (100 mm), diam. 3 mm, bayonet-shaped, sharp/sharp, consisting of FM726R, FM731R
Catalog Number
FM721R
Brand Name
XS
Version/Model Number
FM721R
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
GZX
Product Code Name
INSTRUMENT, MICROSURGICAL
Public Device Record Key
c6246c41-d4da-437a-b84d-46e69b9c6287
Public Version Date
September 26, 2022
Public Version Number
2
DI Record Publish Date
April 23, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |