Duns Number:121464288
Device Description: Surgical Graspers MI-3526 (Miami Instrument Wide DeBakey Grasper, Modular Handle, Standard Surgical Graspers MI-3526 (Miami Instrument Wide DeBakey Grasper, Modular Handle, Standard Handle)
Catalog Number
-
Brand Name
Vitalitec Graspers
Version/Model Number
MI-3526
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
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
ce4209e3-c714-4d91-a025-854dd9d631a5
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
December 13, 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 | 163 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 72 |