Duns Number:005192885
Device Description: Overflow Safety Trap
Catalog Number
7725-0365-901
Brand Name
Sure-Trap
Version/Model Number
70365
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2020
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
-
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
KDP
Product Code Name
Regulator, Vacuum
Public Device Record Key
ad4de97f-a8e4-4ae6-b15f-df05c7590d04
Public Version Date
April 30, 2020
Public Version Number
5
DI Record Publish Date
September 25, 2017
Package DI Number
08688250002627
Quantity per Package
50
Contains DI Package
08688250002597
Package Discontinue Date
April 30, 2020
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6453 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 208 |