Duns Number:801380697
Device Description: NexPak Intranasal Splint is a sterile flexible foam pad comprised of a lyophilized mixture NexPak Intranasal Splint is a sterile flexible foam pad comprised of a lyophilized mixture of starch polysaccharide and polysaccharide binders. NexPak Intranasal Splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and nasal cavity. The intranasal splint is placed in the nasal cavity after surgery or trauma.
Catalog Number
-
Brand Name
NexPak
Version/Model Number
9110524
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
LYA
Product Code Name
Splint, Intranasal Septal
Public Device Record Key
262ca99e-eba3-4f51-b0b9-488d4318c01b
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
September 30, 2020
Package DI Number
00858439001620
Quantity per Package
5
Contains DI Package
00858439001613
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 | 9 |
| U | Unclassified | 7 |