Duns Number:030479000
Device Description: M&S DENTAL BITE-RITE BITE REGULAR SET 50 mL CART
Catalog Number
BIT-9001
Brand Name
BITE-RITE
Version/Model Number
BIT-9001
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
ELW
Product Code Name
Material, Impression
Public Device Record Key
f60f93ff-e160-47e8-8ab9-77a76476dc28
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 05, 2017
Package DI Number
20818524020176
Quantity per Package
10
Contains DI Package
10818524020179
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |