Duns Number:003687733
Device Description: Boot Cover, ChemTech, Tunneled Elastic Top, Butterfly Style, Ankle Ties, Sonic Weld Seams, Boot Cover, ChemTech, Tunneled Elastic Top, Butterfly Style, Ankle Ties, Sonic Weld Seams, Yellow XL.
Catalog Number
BT-K1413-B
Brand Name
Critical Cover
Version/Model Number
BT-K1413-B
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"
-
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
8d77c104-668d-4836-b3a5-4dce513fd5d3
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
July 16, 2018
Package DI Number
20817583021308
Quantity per Package
1
Contains DI Package
10817583021301
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |