Duns Number:111322165
Device Description: Phlebotomy Sharps Container 1 quart - RED
Catalog Number
-
Brand Name
Oak Ridge Products
Version/Model Number
0310-1500
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130281,K130281
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
b1f6e617-9e9c-43b7-9659-f5527b790d64
Public Version Date
March 08, 2021
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
10865273000013
Quantity per Package
80
Contains DI Package
00865273000016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |