Duns Number:551540334
Device Description: Label printer cable for SentieroThe Label Printer cable is not a medical device and was in Label printer cable for SentieroThe Label Printer cable is not a medical device and was introduced to GUDID by mistake. Commercial Distrbution as medical Device ended with correct calssification and introduction of corresponding labeling.
Catalog Number
-
Brand Name
Label Printer Cable
Version/Model Number
100199
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2017
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
K133012
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
2f58b63e-cea8-4fe4-b3d8-b84cc2f66ae1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |