Duns Number:002348191
Device Description: BiteGard Oral Bite Block
Catalog Number
5495-00
Brand Name
HUDSON RCI
Version/Model Number
IPN044977
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
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
274a5a3a-18b3-4634-895b-76af26730ef1
Public Version Date
October 16, 2018
Public Version Number
1
DI Record Publish Date
September 15, 2018
Package DI Number
24026704581652
Quantity per Package
50
Contains DI Package
04026704581658
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |