Duns Number:801895244
Device Description: Two-Trigger Multi-Tip Cryosurgical System for N2O
Catalog Number
-
Brand Name
Wallach LL100
Version/Model Number
900001
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
-
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
K803311
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
b9ae72a7-7207-47a9-9bd3-2dddf828f8ff
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
August 03, 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 | 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 |