Duns Number:079641356
Device Description: Modular Carbon Fiber Handle Insert, FENESTRATED Grasp Forceps, Slightly Flat JAWS, DOUBLE Modular Carbon Fiber Handle Insert, FENESTRATED Grasp Forceps, Slightly Flat JAWS, DOUBLE ACTION, 5mmx33cm
Catalog Number
96-1042Q
Brand Name
Symmetry Surgical Rapidclean®
Version/Model Number
96-1042Q
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
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
d0e3dcac-2866-4d51-b924-4ca710f35b43
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 27, 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 |