Duns Number:006999858
Device Description: Patient Gown, Century Cloth, Kaleidoscope Yellow, 3 Armhole, Wrap Around, No Ties or Snaps Patient Gown, Century Cloth, Kaleidoscope Yellow, 3 Armhole, Wrap Around, No Ties or Snaps, Bias Bound Neck / Armhole / Front & Back Openings, Size 5XL
Catalog Number
74288890
Brand Name
PATIENT GOWN
Version/Model Number
74288890
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)
Yes
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
07013885-b33a-4c92-a8bf-5241b2e2c83b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 29, 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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |