Duns Number:279456896
Device Description: This polyethylene x-ray bouffant cover will offer maximum protection against cross-contami This polyethylene x-ray bouffant cover will offer maximum protection against cross-contamination when covering your x-ray material, microscopes or dental lights.Internal diameter: 20cm.External diameter: 50cm.
Catalog Number
HY-63115
Brand Name
HYGITECH
Version/Model Number
HY-63115
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
f2dd1ce9-8f02-40e0-b24b-28405ed37947
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
November 25, 2020
Package DI Number
03615140003421
Quantity per Package
50
Contains DI Package
03615140003414
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |