Duns Number:006261481
Device Description: ELECTRODE 9670590 5BX LOCALISA
Catalog Number
-
Brand Name
LOCALISA®
Version/Model Number
9670590
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
K002869,K002869
Product Code
DQK
Product Code Name
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Public Device Record Key
f4d0b375-3710-43fa-bdca-d94405d713fb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 30, 2016
Package DI Number
20643169006878
Quantity per Package
5
Contains DI Package
00643169006874
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |