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)
Catalog Number
D601
Brand Name
Sensimatic™
Version/Model Number
D601
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2019
Issuing Agency
In HIBCC
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
993f35a8-0a0d-46c2-8e65-3ed4cae9f3f2
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
September 23, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |