Duns Number:023904428
Device Description: 8GL - Sharps Red
Catalog Number
-
Brand Name
McKesson
Version/Model Number
2266
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"
Yes
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
K071517,K071517
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
e4c4c195-0d4b-4175-9252-971c9c472e7e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
40612479209563
Quantity per Package
9
Contains DI Package
10612479209555
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |