Duns Number:025460908
Device Description: CONTAINER,SHARPS,3 GAL, FLAP, RED
Catalog Number
MDS705204
Brand Name
Medline
Version/Model Number
MDS705204
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
-
Product Code
MMK
Product Code Name
Container, sharps
Public Device Record Key
51b5b6a2-56b6-4ec2-84c6-42cddb4a97d8
Public Version Date
December 03, 2020
Public Version Number
1
DI Record Publish Date
November 25, 2020
Package DI Number
20193489003779
Quantity per Package
10
Contains DI Package
10193489003772
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 |