Duns Number:080935429
Device Description: Protective Underwear,X-Large,Extra Heavy
Catalog Number
1225
Brand Name
Sure Care
Version/Model Number
1225
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
-
Product Code
EYQ
Product Code Name
GARMENT, PROTECTIVE, FOR INCONTINENCE
Public Device Record Key
b5a98cc2-81ea-4155-8a6a-a2a2f02a7d2e
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 22, 2018
Package DI Number
10884527001132
Quantity per Package
48
Contains DI Package
20884527001139
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |