FDA.reportPublic FDA data

NexPak X

Primary DI
00858439001637
Brand
NexPak X
Company
HEMOSTASIS, LLC
Model
9110534
Device description
NexPak X Intranasal Splint is a sterile flexible foam pad comprised of a lyophilized mixture of starch polysaccharide and polysaccharide binders. NexPak X 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.
Published
2020-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858439001644PackageGS15In Commercial Distribution
00858439001637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858439001644008584390016448584390016440858439001644
00858439001637008584390016378584390016370858439001637

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Inch
Width0.6Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Contacts#

Phone, Email table
PhoneEmail
+6518551466customerservice@hemostasisllc.com

Regulatory Flags#

DUNS number
801380697
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858439001552BoneSeal 2x2.5 gram Ingot95500742019-05-06
00858439001699ExcelArrest XT 2x2 Hemostatic Patch92102232020-11-20
00858439001774AeroClear97700132020-11-30
00858439001279PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint92105642020-02-20
00858439001309PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint92105742020-02-20
00858439001330PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint92105842020-02-20
00858439001361PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal Splint92106042020-02-20
00858439001385PosiSep C92107542020-02-20
00858439001415PosiSep C²92107642020-02-20
00858439001675PosiSep C 0.6 x 2.092108542020-09-30
00858439001903"PosiSep X2 0.8"" x 2.3"""92106152021-05-03
00858439001880"PosiSep X2 0.7"" x 1.7"""92106142021-05-03
00858439001248PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint92105542020-02-20
00858439001972NexStat 1gm91301542021-05-03
00858439001910PosiSep X2 0.8" x 2.3"92106152021-05-03
00858439001989NexStat 1gm91301542021-05-03
00858439001613NexPak91105242020-09-30
00858439001705ExcelArrest XT 2x2 Hemostatic Patch92102232020-11-20
00858439001262NexStat Plus 2gm94300142020-09-30
00858439001323NexStat Plus 3gm94300342020-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850056665305ORCA FoamOrca Products, LLCLYA2026-05-07
16975560670042Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670059Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670066Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670073Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670080Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670097Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670103Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670110Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670257Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670264Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670271Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670288Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670295Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670301Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670045Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670052Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670069Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670076Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670083Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670090Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670100Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670117Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
04250381820537Expanding sinus tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250381820544Expanding sinus tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676730008MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731104Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731111Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731128Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731135Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07