Duns Number:202822052
Device Description: Drapes that are individually packaged for one-time use to create an optimal lighting envir Drapes that are individually packaged for one-time use to create an optimal lighting environment for imaging wounds while using the MolecuLight i:X.
Catalog Number
-
Brand Name
MolecuLight DarkDrape
Version/Model Number
1426
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
98190f10-5dce-4b45-88b4-02d10e56b241
Public Version Date
January 13, 2022
Public Version Number
1
DI Record Publish Date
January 05, 2022
Package DI Number
00628110259301
Quantity per Package
50
Contains DI Package
00628110259295
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case of 50
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |