Duns Number:021717889
Device Description: Endoscopic Bite Block with Elastic Cloth Strap
Catalog Number
SBT-321
Brand Name
Blox™
Version/Model Number
SBT-321
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"
-
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
1d97febb-ad03-4570-8e63-c6d6afecbe5d
Public Version Date
January 01, 2019
Public Version Number
1
DI Record Publish Date
December 01, 2018
Package DI Number
00816849016764
Quantity per Package
100
Contains DI Package
00840253108838
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |