Duns Number:009900424
Device Description: New Indifferent Plate & Red Cable for Sensimatic® 600SE (Complies with New FDA Lead Wire R New Indifferent Plate & Red Cable for Sensimatic® 600SE (Complies with New FDA Lead Wire Regulations)(Korea)
Catalog Number
D601-K
Brand Name
Sensimatic®
Version/Model Number
D601-K
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
-
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
-
Product Code
EKZ
Product Code Name
Unit, Electrosurgical, And Accessories, Dental
Public Device Record Key
4041b6c7-bae4-4b28-97ff-04c95d36292f
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 10, 2021
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |