Duns Number:803689769
Device Description: Custom endoscopic bite block which can also incorporate an oral/nasal cannula.
Catalog Number
-
Brand Name
ENDOCAP Bite Block
Version/Model Number
1709
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
a4a0aed1-b1c5-4b1e-96a4-5d1977ee8833
Public Version Date
April 25, 2018
Public Version Number
1
DI Record Publish Date
March 25, 2018
Package DI Number
10856824006189
Quantity per Package
40
Contains DI Package
00856824006182
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |