Duns Number:007941230
Device Description: Cover Shoe Fluid-Resistant Durable Elastic Band Upper Extra-Large Spun Bond Polypropylene Cover Shoe Fluid-Resistant Durable Elastic Band Upper Extra-Large Spun Bond Polypropylene Blue Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
77729
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
FXP
Product Code Name
COVER, SHOE, OPERATING-ROOM
Public Device Record Key
5cec5e21-3ec8-45a3-a7e5-30bb4c3de296
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
December 03, 2020
Package DI Number
50885632105331
Quantity per Package
3
Contains DI Package
30885632105337
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |