Duns Number:023904428
Device Description: Bite Block Plastic Disposable Green / Non-Sterile / 1.4 x 1 inch
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-429
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)
-
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
a3b911b7-15e3-4dc5-bcb5-cc55d2db8c52
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
Package DI Number
40612479186055
Quantity per Package
10
Contains DI Package
20612479186044
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |