NexPak X

FDA UDI

Class I (US FDA UDI)

by Hemostasis, LLC

Identity

Trade Name: NexPak X FDA UDI
Generic Name: Intranasal splint, non-biodegradable FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 9110534 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00858439001637 FDA UDI
FDA Product Code: LYA FDA UDI
GMDN Term: Intranasal splint, non-biodegradable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4780 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 2.0 Inch FDA UDI
Width — 0.6 Inch FDA UDI

Category: Intranasal splint, non-biodegradable

NexPak X by Hemostasis, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Hemostasis, LLC

Sources (1)

FDA UDI 9a6b6ba0-42aa-4bea-b3bb-9f2c88339591 36 fields · synced May 30, 2026