Duns Number:315018218
Device Description: PERNECZKY/CRISTANTE XS Tumor Forceps, shaft only, working length: 2 3/4", (70 mm), diam. 3 PERNECZKY/CRISTANTE XS Tumor Forceps, shaft only, working length: 2 3/4", (70 mm), diam. 3 mm, sharp/sharp
Catalog Number
FM725R
Brand Name
XS
Version/Model Number
FM725R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 10, 2021
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
9f501898-3e6c-4065-80e2-4938439a22df
Public Version Date
May 28, 2021
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 |