Duns Number:025460908
Device Description: CONTAINER,RCRA,18 GAL,BLK,PORT LID
Catalog Number
MDS708318
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDS708318
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
K071517,K071517
Product Code
MMK
Product Code Name
Container, sharps
Public Device Record Key
fc9bc376-1e0b-41e0-ae40-7b5a79f6da4c
Public Version Date
October 11, 2021
Public Version Number
1
DI Record Publish Date
October 01, 2021
Package DI Number
20888277408101
Quantity per Package
7
Contains DI Package
10888277408104
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |