Duns Number:801895244
Device Description: Loop Electrode Size 0.8mm Diameter x 16mm Needle (5.5cm Shaft)
Catalog Number
-
Brand Name
Wallach
Version/Model Number
909135
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"
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
K020711,K020711
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
1c4e2b00-7242-425b-abfd-9024dce1434a
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
May 25, 2016
Package DI Number
20888937009402
Quantity per Package
5
Contains DI Package
00888937009408
Package Discontinue Date
-
Package Status
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |