Duns Number:627879687
Device Description: The Bite Block Intermediate, Latex Free Strap is used to protect the endoscope insertion t The Bite Block Intermediate, Latex Free Strap is used to protect the endoscope insertion tube from being bitten by the patient.
Catalog Number
00712809
Brand Name
NA
Version/Model Number
00712809
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
4c31448b-d1c5-4ba7-b863-5c949cb7e303
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
10724995184206
Quantity per Package
100
Contains DI Package
00724995184209
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |