Duns Number:025460908
Device Description: DBD-CONTAINER,SHARPS,18 GAL,RED,FLAP
Catalog Number
MDS705218F
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDS705218F
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
K132767,K132767
Product Code
MMK
Product Code Name
Container, sharps
Public Device Record Key
59bf1cfc-6c9b-4cf7-90ce-5b00f59c55a4
Public Version Date
February 28, 2022
Public Version Number
1
DI Record Publish Date
February 18, 2022
Package DI Number
40888277171146
Quantity per Package
5
Contains DI Package
10888277171145
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 |