Duns Number:117996054
Device Description: Remnova Complete Bite Block, perioperative bite block and endotracheal tube (ETT) stabiliz Remnova Complete Bite Block, perioperative bite block and endotracheal tube (ETT) stabilizer. Physician designed and expertly engineered to protect patients’ teeth, mouths, and lives.
Catalog Number
RCB01
Brand Name
Remnova Complete Bite Block - Adult
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 20, 2021
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)
-
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
443391c5-7f53-4449-9b03-a2aa2f7c96c4
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
October 20, 2021
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 | 2 |