Duns Number:043835081
Device Description: Lightweight disposable fabric wipes used to remove dust, hair, dirt and smudges from imagi Lightweight disposable fabric wipes used to remove dust, hair, dirt and smudges from imaging surface.
Catalog Number
-
Brand Name
Monarch PSP Cleaning Wipes
Version/Model Number
B8910
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IWZ
Product Code Name
Film, Radiographic
Public Device Record Key
01f97f95-7695-41bf-bb0a-0eb7d81dfbb4
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
July 06, 2018
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |