NexPak
GUDID 00858439001620
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.
HEMOSTASIS, LLC
Intranasal splint, non-biodegradable| Primary Device ID | 00858439001620 |
| NIH Device Record Key | 262ca99e-eba3-4f51-b0b9-488d4318c01b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NexPak |
| Version Model Number | 9110524 |
| Company DUNS | 801380697 |
| Company Name | HEMOSTASIS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
| Width | 0.5 Inch |
| Length | 1.75 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858439001613 [Primary] |
| GS1 | 00858439001620 [Package] Contains: 00858439001613 Package: Carton [5 Units] In Commercial Distribution |
FDA Product Code
| LYA | Splint, Intranasal Septal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-08 |
| Device Publish Date | 2020-09-30 |
Devices Manufactured by HEMOSTASIS, LLC
| 00858439001880 - PosiSep X2 0.7" x 1.7" | 2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e |
| 00858439001910 - PosiSep X2 0.8" x 2.3" | 2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e |
| 00858439001989 - NexStat 1gm | 2021-05-11 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th |
| 00858439001774 - AeroClear | 2020-12-08 The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. I |
| 00858439001705 - ExcelArrest XT 2x2 Hemostatic Patch | 2020-11-30 ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in ste |
| 00858439001293 - NexStat Plus 2gm | 2020-10-08 The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide |
| 00858439001408 - NexStat Plus 3gm | 2020-10-08 The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide |
| 00858439001439 - NexStat | 2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th |
Trademark Results [NexPak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEXPAK 98588717 not registered Live/Pending |
Capsa Solutions LLC 2024-06-06 |
 NEXPAK 98588703 not registered Live/Pending |
Capsa Solutions LLC 2024-06-06 |
 NEXPAK 98501666 not registered Live/Pending |
Nextera Packaging 2024-04-15 |
 NEXPAK 85161664 4250581 Live/Registered |
Hemostasis, LLC 2010-10-26 |
 NEXPAK 78774533 3201168 Dead/Cancelled |
Nexpak de Mexico S.A de C.V. 2005-12-15 |
 NEXPAK 78774449 3171273 Dead/Cancelled |
Nexpak de Mexico S.A. de C.V. 2005-12-15 |
 NEXPAK 77514857 3567648 Dead/Cancelled |
AUTRONIC PLASTICS, INC. 2008-07-03 |
 NEXPAK 76676023 3371253 Live/Registered |
LEE, HWA SUN 2007-04-26 |
 NEXPAK 76007155 2970935 Dead/Cancelled |
NEXPAK CORPORATION 2000-03-22 |
 NEXPAK 75933095 2525994 Dead/Cancelled |
NEXPAK CORPORATION 2000-02-23 |
 NEXPAK 75329682 2205276 Dead/Cancelled |
Medicart, L.L.C. 1997-07-24 |
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