Duns Number:606939072
Device Description: Electro Lavage L Hook Double Bottle
Catalog Number
0600-3113-000
Brand Name
Electro Lavage
Version/Model Number
0600-3113-000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 10, 2020
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
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
9ce9485d-a296-45e6-9c80-87bae256c103
Public Version Date
January 13, 2020
Public Version Number
2
DI Record Publish Date
January 25, 2019
Package DI Number
10817984010478
Quantity per Package
10
Contains DI Package
00817984010471
Package Discontinue Date
January 10, 2020
Package Status
Not in Commercial Distribution
Package Type
Inner pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 57 |