Duns Number:083381202
Device Description: RPRPA-MD (PATIENT APRON, .5MM PRESTIGE, PATIENT APRON, 18 X 24, MD )
Catalog Number
-
Brand Name
PATIENTAPRON
Version/Model Number
RPRPA-MD
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KPY
Product Code Name
Shield, Protective, Personnel
Public Device Record Key
e4d52c03-1988-42fe-90f4-f4843ac6c032
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
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 | 12773 |
| 3 | A medical device with high risk that requires premarket approval | 1 |