Duns Number:055527753
Device Description: Moore Sharps Container 1.7 Quart Red
Catalog Number
93265
Brand Name
Medegen Medical products
Version/Model Number
93265
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K942054,K942054
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
470c3c99-f936-4b0c-b4b7-dcf67aa7e086
Public Version Date
April 02, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
40607415003664
Quantity per Package
20
Contains DI Package
10607415003557
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 108 |