Duns Number:060396278
Device Description: Patient specific, 3D printed, single use postoperative nasal splints to control edema base Patient specific, 3D printed, single use postoperative nasal splints to control edema based a patient’s treatment plan. RX only, non-diagnostic.
Catalog Number
-
Brand Name
Splint LT Kit
Version/Model Number
MSTL
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
EPP
Product Code Name
Splint, Nasal
Public Device Record Key
bb3dfc9f-5af7-4938-a869-9bb44375c502
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |