Duns Number:560455084
Device Description: Applied to operative and surgical wounds or indwelling catheter; be used as infants’ umbi Applied to operative and surgical wounds or indwelling catheter; be used as infants’ umbilical cord wound dressing
Catalog Number
-
Brand Name
Huibo Medical
Version/Model Number
10*10cm
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
KOZ
Product Code Name
Beads, Hydrophilic, For Wound Exudate Absorption
Public Device Record Key
63acc98d-4ca1-4926-9e0a-30147fc96df8
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
January 21, 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 |
|---|---|---|
| 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. | 4 |