Duns Number:070637129
Device Description: STRAP, ANTI-SNORING, LATEX-FREE, BUTTONS, REUSABLEContains:1 Head Strap,1 Chin Strap,2 Chi STRAP, ANTI-SNORING, LATEX-FREE, BUTTONS, REUSABLEContains:1 Head Strap,1 Chin Strap,2 Chin Liners and1 Lip Strap.
Catalog Number
6200
Brand Name
Urocare® Latex-Free Anti-Snoring Strap
Version/Model Number
6200
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"
Yes
For Single-Use
-
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
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
90ffc490-e491-4314-9002-cd3aeff1df2a
Public Version Date
June 29, 2018
Public Version Number
1
DI Record Publish Date
May 29, 2018
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 | 140 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |