Duns Number:055527753
Device Description: STACKABLE CONTAINER 3 GALLON W/LID
Catalog Number
8710
Brand Name
Medegen Medical products
Version/Model Number
8710
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2020
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
K942054,K942054
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
ec25f5cd-b372-426e-b2be-a7ce06479c71
Public Version Date
June 01, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
H3628710TF2
Quantity per Package
12
Contains DI Package
H3628710TF0
Package Discontinue Date
June 01, 2020
Package Status
Not 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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 108 |