Duns Number:063865158
Device Description: Spand-Gel Hydrogel Dressing Sheet - Half Face Mask - Sterile
Catalog Number
SPHFM2
Brand Name
Spand-Gel
Version/Model Number
SPHFM2
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAE
Product Code Name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Public Device Record Key
643eec0f-2914-4956-add1-0118a470c756
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
June 11, 2019
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 | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |