Duns Number:141668116
Device Description: Sunset Ruby Style Chin Strap - Small
Catalog Number
CS007S
Brand Name
Sunset Ruby Style Chin Strap - Small
Version/Model Number
CS007S
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
-
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
BTK
Product Code Name
Strap, Head, Gas Mask
Public Device Record Key
739b1aa4-e4be-40d5-b582-c3e41b6b06bb
Public Version Date
October 18, 2018
Public Version Number
1
DI Record Publish Date
September 17, 2018
Package DI Number
10848530040571
Quantity per Package
100
Contains DI Package
00848530040574
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |