Duns Number:141668116
Device Description: Deluxe Chinstrap, Size Small
Catalog Number
CS004S
Brand Name
Deluxe Chinstrap — Small
Version/Model Number
CS004S
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
e3099a8b-f28b-4d96-8287-439db8b34740
Public Version Date
September 19, 2018
Public Version Number
4
DI Record Publish Date
May 25, 2018
Package DI Number
10848530080096
Quantity per Package
150
Contains DI Package
00848530080099
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 |