Duns Number:079641356
Device Description: Modular Cfh Atraumatic Grasper, 3X4 Teeth, Double Action, 5Mmx45Cm, Ratchet Lock Handle
Catalog Number
96-1078R-45
Brand Name
Symmetry Rapidclean® ALLIS
Version/Model Number
96-1078R-45
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 9999
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
K974382
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
cffce25a-77fd-4ba5-8ab0-8ce75543e60c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 13, 2016
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 | 7981 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3309 |