Duns Number:319414785
Device Description: Tracheal Compresses with zigzag slit, for neonates and children
Catalog Number
-
Brand Name
TRACOE® care
Version/Model Number
REF 961
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing,wound,occlusive
Public Device Record Key
f258456f-c8d9-45fd-83d8-830542b0d061
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
March 15, 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 | 88 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1963 |