Duns Number:062388929
Device Description: Blue Polyethylene Cover Gown, Universal Size, Thumb Loops, Case of 75 each
Catalog Number
5221
Brand Name
Strong Manufacturers
Version/Model Number
5221
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
01b4222b-b0d1-490a-9f28-26e8a70b3f6d
Public Version Date
December 30, 2021
Public Version Number
1
DI Record Publish Date
December 22, 2021
Package DI Number
10850005354212
Quantity per Package
75
Contains DI Package
00850005354215
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 | 79 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |