Duns Number:062388929
Device Description: Yellow SMS Disposable Cover Gown, XL Size, Full Back, Neck Ties and Elastic Cuffs, Case of Yellow SMS Disposable Cover Gown, XL Size, Full Back, Neck Ties and Elastic Cuffs, Case of 50 each
Catalog Number
5202
Brand Name
Strong Manufacturers
Version/Model Number
5202
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
f8248a89-7215-48df-a2a1-3432d9680070
Public Version Date
December 30, 2021
Public Version Number
1
DI Record Publish Date
December 22, 2021
Package DI Number
10853927007761
Quantity per Package
50
Contains DI Package
00853927007764
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 |