Duns Number:480868538
Device Description: ECG 10-extension wires IEC dot clip 0.9 m radiolucent
Catalog Number
2.410304
Brand Name
Schiller ECG extension wires
Version/Model Number
2.410304
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
K012226
Product Code
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
c3b0baa7-6758-4261-85a9-7e54f623670e
Public Version Date
February 10, 2020
Public Version Number
3
DI Record Publish Date
September 21, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |