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PuraSinus 5mL

FDA UDI

Class II (US FDA UDI)

by 3-D Matrix, Inc.

Identity

Trade Name
PuraSinus 5mL FDA UDI
Generic Name
Intranasal splint, biodegradable FDA UDI
Device Name
PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL) FDA UDI
Model / Reference
651-009 FDA UDI
Description
PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL) FDA UDI

Identifiers

Primary DI / UDI-DI
00860001820829 FDA UDI
510(k) Number
K183015 FDA UDI
FDA Product Code
NHB FDA UDI
GMDN Term
Intranasal splint, biodegradable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intranasal splint, biodegradable

PuraSinus 5mL by 3-D Matrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intranasal splint, biodegradable.

Cleared under the same submission

K183015 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3-D Matrix, Inc.

Sources (1)

  • FDA UDI bd7c5e5e-b04c-4b37-87ca-ebbb9bd92bb2 35 fields · synced May 30, 2026