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TurbAlign

FDA UDI

Class I (US FDA UDI)

by Spirair

Identity

Trade Name
TurbAlign FDA UDI
Generic Name
Intranasal splint, biodegradable FDA UDI
Device Name
Single pouch FDA UDI
Model / Reference
FG-0019 FDA UDI
Description
Single pouch FDA UDI

Identifiers

Catalog Number
TBLN001 FDA UDI
Primary DI / UDI-DI
00860011696322 FDA UDI
510(k) Number
K243655 FDA UDI
FDA Product Code
LYA FDA UDI
GMDN Term
Intranasal splint, 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

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

No

FDA UDI

Category: Intranasal splint, biodegradable

TurbAlign by Spirair — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intranasal splint, biodegradable.

Cleared under the same submission

K243655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spirair

Sources (1)

  • FDA UDI 2a970bd4-d752-4610-bc13-33f59d05aeda 35 fields · synced Jun 8, 2026