Duns Number:830069063
Device Description: Coverall, X-Large, White, Economy, Single Use, Disposable , Zipper Front, Open Leg, Latex Coverall, X-Large, White, Economy, Single Use, Disposable , Zipper Front, Open Leg, Latex Free
Catalog Number
-
Brand Name
MH
Version/Model Number
3006XL
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
53064d57-ed3e-48de-a609-2dc118ecb4a6
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
November 15, 2020
Package DI Number
10850018327159
Quantity per Package
25
Contains DI Package
00850018327152
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 | 9 |