Duns Number:883475274
Device Description: Thyroid Collar with Strap and Ring
Catalog Number
TC-2
Brand Name
Stevens-Moon
Version/Model Number
TC-2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IWO
Product Code Name
Apron, Protective
Public Device Record Key
fb4c7c5b-f165-4be1-81e7-781736c635b6
Public Version Date
October 04, 2022
Public Version Number
1
DI Record Publish Date
September 26, 2022
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 | 83 |