Duns Number:043537671
Device Description: HENRY SCHEIN DENTAL TRAINING FOR DENTAL SURGURY. THIS PACK CONTAINS PATIENT PPE USED IN SU HENRY SCHEIN DENTAL TRAINING FOR DENTAL SURGURY. THIS PACK CONTAINS PATIENT PPE USED IN SUPPORT OF ORAL SURGERY. HENRY SCHEIN PRODUCT FOR NSU.
Catalog Number
-
Brand Name
PATIENT PACK NSU V2
Version/Model Number
570-2902
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PWL
Product Code Name
Oral Surgery Tray
Public Device Record Key
0c75c599-a1d5-49f9-ac3a-8ba67f3d3f70
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
May 03, 2022
Package DI Number
M75257029025
Quantity per Package
30
Contains DI Package
M75257029021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
outer box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |