Duns Number:131855157
Device Description: Size: 1.0 x 51 x 76 mm; Type: Silicone
Catalog Number
60-314
Brand Name
Custom Nasal Splint
Version/Model Number
60-314
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
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
LYA
Product Code Name
Splint, Intranasal Septal
Public Device Record Key
b310d67d-0ece-4254-b461-a846ea75f930
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
34063107102371
Quantity per Package
10
Contains DI Package
14063107102377
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 121 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 211 |
| U | Unclassified | 1 |