Duns Number:023904428
Device Description: Over-the-Head Protective Procedure Gown POLY COATED , FLUID RESISTANT OVERHEAD , THUMB LOO Over-the-Head Protective Procedure Gown POLY COATED , FLUID RESISTANT OVERHEAD , THUMB LOOP WITH ELASTIC CUFF , APRON CLOSURE , BLUE UNIVERSAL
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-OHBPOLY
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
OEA
Product Code Name
Non-Surgical Isolation Gown
Public Device Record Key
6ddd85a5-0a06-4c61-8338-6eede982b3de
Public Version Date
October 30, 2019
Public Version Number
1
DI Record Publish Date
October 22, 2019
Package DI Number
00612479203204
Quantity per Package
10
Contains DI Package
00612479203198
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 |