Duns Number:108179458
Device Description: D.Zap Single Insertion-Used in KTF1001, not sold individually
Catalog Number
66-IT-40L
Brand Name
Insertion Tube
Version/Model Number
66-IT-40L-00851
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
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
K033173
Product Code
GZL
Product Code Name
ELECTRODE, DEPTH
Public Device Record Key
4bb614d8-4211-428d-8a7b-8edcdd572856
Public Version Date
April 06, 2022
Public Version Number
1
DI Record Publish Date
March 29, 2022
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |