Duns Number:007941230
Device Description: Shoe Cover Regular Spunbond Polyproylene Blue Not made with Natural Rubber Latex MediChoic Shoe Cover Regular Spunbond Polyproylene Blue Not made with Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
77731
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
FXP
Product Code Name
COVER, SHOE, OPERATING-ROOM
Public Device Record Key
39d5c57d-7490-4a0b-ae6b-abc2bf23e873
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
March 23, 2021
Package DI Number
30885632287477
Quantity per Package
10
Contains DI Package
20885632287470
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 |