Duns Number:202822052
Device Description: Sterile protective cover for the MolecuLight i:X to be used in a surgical environment.
Catalog Number
-
Brand Name
i:X Sterile Surgical Sleeve Convenience Kit
Version/Model Number
1859
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
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
ec95447b-dc15-44e4-b9d3-0f252c0b75f5
Public Version Date
January 13, 2022
Public Version Number
1
DI Record Publish Date
January 05, 2022
Package DI Number
00628110259356
Quantity per Package
25
Contains DI Package
00628110259363
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case of 25
| 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 |