Duns Number:012430880
Device Description: Maxima 2000 Curing Light Sheath
Catalog Number
5700542
Brand Name
Henry Schein
Version/Model Number
5700542
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PEM
Product Code Name
Dental barriers and sleeves
Public Device Record Key
d0648d95-9821-4c91-a494-a2fc7f24010f
Public Version Date
December 07, 2020
Public Version Number
4
DI Record Publish Date
March 30, 2017
Package DI Number
10304040051891
Quantity per Package
500
Contains DI Package
00304040051894
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 |