Duns Number:317654283
Device Description: ErgoFlex handle with HF-connector, rotating Rotation b ErgoFlex handle with HF-connector, rotating Rotation blocked when closed.
Catalog Number
1292-30-00
Brand Name
ErgoFlex
Version/Model Number
1292-30-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2025
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"
Yes
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
3843aab6-3164-42bd-b8be-a081805094b9
Public Version Date
March 16, 2021
Public Version Number
2
DI Record Publish Date
March 08, 2019
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |