Duns Number:047063695
Device Description: Grasper Atraumatic 34mm Blade with Ratchet 33cm Disposable
Catalog Number
OS-33-5-MG34R
Brand Name
Grasper Atraumatic 34mm Blade with Ratchet 33cm Disposable
Version/Model Number
OS-33-5-MG34R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 07, 2019
Issuing Agency
In HIBCC
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
Yes
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
88579736-86e2-4e27-9046-05613144f8bf
Public Version Date
November 07, 2019
Public Version Number
3
DI Record Publish Date
November 07, 2016
Package DI Number
B354OS335G34R10
Quantity per Package
10
Contains DI Package
B354OS335G34R0
Package Discontinue Date
November 07, 2019
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 271 |