Duns Number:835465063
Device Description: ELECTRODE 8227510 5PK PR 2CH18MM 2M ROHS
Catalog Number
-
Brand Name
NA
Version/Model Number
8227510
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
K024316,K024316
Product Code
GXZ
Product Code Name
ELECTRODE, NEEDLE
Public Device Record Key
2f8c575e-d68c-4f1f-9a1c-89a3f88f15b8
Public Version Date
February 26, 2021
Public Version Number
4
DI Record Publish Date
March 26, 2018
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 | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |