Duns Number:548298805
Device Description: It is applicable to the health protection of the wearer in the ordinary medical environmen It is applicable to the health protection of the wearer in the ordinary medical environment without the risk of liquid and splashing.
Catalog Number
-
Brand Name
Zhibo
Version/Model Number
1
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
K182514
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
2a034cab-4345-4722-9163-7178fc600ce8
Public Version Date
September 14, 2020
Public Version Number
1
DI Record Publish Date
September 04, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |