Duns Number:315304071
Device Description: HANDLE PISTOL SHAPED with locking mechanism, non-rotatable, without HF-connection, for us HANDLE PISTOL SHAPED with locking mechanism, non-rotatable, without HF-connection, for use with Moduline and RIWO-GRIP sheath tubes, reusable
Catalog Number
8393.0008
Brand Name
MODULINE
Version/Model Number
83930008
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)
-
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
5fbcb37b-2fe8-49fa-9cdc-fb6a9b518e74
Public Version Date
February 11, 2022
Public Version Number
5
DI Record Publish Date
September 23, 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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |