Duns Number:560455084
Device Description: 1.Comfortable and adhesive: Soft silicone with excellent performance; comfortable; strippi 1.Comfortable and adhesive: Soft silicone with excellent performance; comfortable; stripping without pain; no skin irritation. 2.Slim and light: 0.5mm thickness.3.Invisible and sun-resistant. Close to skin-color; good concealment; strong exclusive.; external use without affecting beauty . 4.Flexible and elastic.5.Easy to cut: Before use, it can be cut economically according to the size of the scar.6.Able to reuse. There is no skin allergy for long time use everyday. Normally, it can be used one week or so.
Catalog Number
-
Brand Name
Huibo Medical
Version/Model Number
6cm*8cm
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"
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For Single-Use
-
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
MDA
Product Code Name
Elastomer, Silicone, For Scar Management
Public Device Record Key
f484633a-f078-45a8-8e67-a73f02d2954d
Public Version Date
January 28, 2020
Public Version Number
1
DI Record Publish Date
January 20, 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 |