Duns Number:030650113
Device Description: Bite Block With White Soft Strap
Catalog Number
1198-60XL
Brand Name
CareGuard®
Version/Model Number
1198-60XL
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MNK
Product Code Name
Endoscopic Bite Block
Public Device Record Key
f30d0ab5-61f2-42d0-a738-e06f60c679b4
Public Version Date
April 10, 2019
Public Version Number
4
DI Record Publish Date
September 17, 2016
Package DI Number
M783119860XL1
Quantity per Package
100
Contains DI Package
M783119860XL0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |