Duns Number:055527753
Device Description: STACKABLE CONTAINER 1 GALLON TRANSLUCENT YELLOW WITH LID
Catalog Number
8706TYV
Brand Name
Medegen Medical products
Version/Model Number
8706TYV
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
K942054,K942054
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
221c68e2-4734-4356-b8a1-8bfffaf660bf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 11, 2017
Package DI Number
H3628706TYV2E
Quantity per Package
12
Contains DI Package
H3628706TYV0
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 108 |