Duns Number:063865158
Device Description: Medibrief Mesh Brief - Size 2X-Large - Size Color Code Purple - Bulk 100/CS
Catalog Number
MB15100
Brand Name
MediBrief
Version/Model Number
MB15100
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
EYQ
Product Code Name
Garment, Protective, For Incontinence
Public Device Record Key
79ef5b26-1e0d-4d46-8b65-0d62c96a5901
Public Version Date
November 07, 2019
Public Version Number
2
DI Record Publish Date
July 01, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |