Duns Number:560455084
Device Description: Mainly applied to superficial wounds with much exudates. 1) first and second degree burn; Mainly applied to superficial wounds with much exudates. 1) first and second degree burn; 2) skin abrasion; 3)be used as second degree dressing when combining with wound fillings
Catalog Number
-
Brand Name
Huibo Medical
Version/Model Number
10*10cm, borderless
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
664a5f5f-71c7-41eb-9cea-830fa3e9ea56
Public Version Date
June 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 |