Duns Number:315304071
Device Description: HANDLE PISTOL SHAPED with locking mechanism, without HF-connection, for use with all ERAG HANDLE PISTOL SHAPED with locking mechanism, without HF-connection, for use with all ERAGON outer sheath tubes, reusable
Catalog Number
83930072
Brand Name
ERAGON MODULAR
Version/Model Number
83930072
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
2bc4363a-76bb-40fd-ae40-0a5e95dba95c
Public Version Date
April 28, 2021
Public Version Number
5
DI Record Publish Date
September 28, 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 |