Duns Number:141668116
Device Description: Deluxe Chinstrap (size large). Extra wide strap evenly distributes pressure to add comfort Deluxe Chinstrap (size large). Extra wide strap evenly distributes pressure to add comfort.
Catalog Number
CS004L
Brand Name
Deluxe Chinstrap — Large
Version/Model Number
CS004L
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
e4298cb3-5b1b-40ed-8f81-f09873692e1e
Public Version Date
August 29, 2018
Public Version Number
1
DI Record Publish Date
July 29, 2018
Package DI Number
10848530080089
Quantity per Package
150
Contains DI Package
00848530080082
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 |