Duns Number:012430880
Device Description: Evacuation Trap Disp 1 7/8
Catalog Number
5701405
Brand Name
Henry Schein
Version/Model Number
5701405
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
EHZ
Product Code Name
Evacuator, oral cavity
Public Device Record Key
ea7bf21f-3815-43b3-b3ba-8009091f130c
Public Version Date
July 03, 2019
Public Version Number
1
DI Record Publish Date
June 25, 2019
Package DI Number
20304040108882
Quantity per Package
8
Contains DI Package
10304040108885
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 |