Duns Number:788472314
Device Description: 12 Foot Disposable Extension Cable with Safe Connect / Screw-Down
Catalog Number
FL-601-97-12-B
Brand Name
NA
Version/Model Number
FL-601-97-12-B
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
-
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
9ef73659-16b6-4dd3-a40c-ca53cdda985f
Public Version Date
May 08, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
20813079021319
Quantity per Package
20
Contains DI Package
10813079021312
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |