Duns Number:012430880
Device Description: MAXIMA MR IMP BITE TRAY
Catalog Number
5701038
Brand Name
Henry Schein
Version/Model Number
5701038
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
EHY
Product Code Name
TRAY, IMPRESSION, PREFORMED
Public Device Record Key
1afb9aea-2dd7-4fbd-9b2d-8eaf252024fa
Public Version Date
February 18, 2019
Public Version Number
1
DI Record Publish Date
January 16, 2019
Package DI Number
20304040108653
Quantity per Package
16
Contains DI Package
10304040108656
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |