Duns Number:012430880
Device Description: Evacuation Traps Disp 2 1/8
Catalog Number
5701406
Brand Name
Henry Schein
Version/Model Number
5701406
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)
-
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
5f85101c-0816-4438-9872-448b45169158
Public Version Date
July 03, 2019
Public Version Number
1
DI Record Publish Date
June 25, 2019
Package DI Number
20304040108899
Quantity per Package
4
Contains DI Package
10304040108892
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 |