Duns Number:180587883
Device Description: Dual Socket 5 Lead Wire Combiner Assembly (Red, Blk, Brn, Wht, Grn)
Catalog Number
-
Brand Name
Patient Lead Wire Set
Version/Model Number
80900-5ATC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
K942321
Product Code
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
6e0ebf40-96a7-4484-a493-ed1470b74cde
Public Version Date
January 03, 2022
Public Version Number
3
DI Record Publish Date
October 23, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 83 |