Duns Number:007941230
Device Description: Boot Full Coverage Impervious Shoe Cover With Breathable Sms Knee-High And Ankle Elastic T Boot Full Coverage Impervious Shoe Cover With Breathable Sms Knee-High And Ankle Elastic Top Blue Non-Skid Tread Latex Free Non-Sterile Extra-Large MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
77722
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
d4207e9f-d189-4522-885a-2d85dd0b3226
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 07, 2020
Package DI Number
50885632103122
Quantity per Package
3
Contains DI Package
30885632103128
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 |