Duns Number:023904428
Device Description: Disposable Gowns Open BACK, FLUID RESISTANT YELLOW ELASTIC CUFFS NECK & WAIST TIES U Disposable Gowns Open BACK, FLUID RESISTANT YELLOW ELASTIC CUFFS NECK & WAIST TIES Universal Fit
Catalog Number
-
Brand Name
McKesson
Version/Model Number
44051100
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"
Yes
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
FME
Product Code Name
Gown, Examination
Public Device Record Key
ef8e0051-1d98-46fd-8f4e-30937f2933aa
Public Version Date
July 22, 2020
Public Version Number
1
DI Record Publish Date
July 14, 2020
Package DI Number
40612479119978
Quantity per Package
5
Contains DI Package
20612479191154
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |