Duns Number:040942451
Device Description: IV Snap Gown O/S Cross Stitch Diamonds Icy Blue. Cell Phone Pocket. Hospital 1 Embroider IV Snap Gown O/S Cross Stitch Diamonds Icy Blue. Cell Phone Pocket. Hospital 1 Embroidery.
Catalog Number
-
Brand Name
Patientstyle
Version/Model Number
200P CSDB O/S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 31, 2025
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
FME
Product Code Name
Gown, Examination
Public Device Record Key
ca001d83-2b63-4d70-bd9b-353d5c588bea
Public Version Date
September 20, 2019
Public Version Number
1
DI Record Publish Date
September 12, 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 | 6 |