Duns Number:153880372
Device Description: Combo Kit: 5qt sharps container; locking wall cabinet; glove holder
Catalog Number
-
Brand Name
Plasti Products
Version/Model Number
145002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
-
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
K970383
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
7b3e9db5-f37f-4011-a938-158456829c23
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |