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SUSTOL Co-packaged Kit

FDA UDI

Class II (US FDA UDI)

by Heron Therapeutics, Inc.

Identity

Trade Name
SUSTOL Co-packaged Kit FDA UDI
Generic Name
Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
Device Name
SUSTOL Co-packaged Kit FDA UDI
Model / Reference
NA FDA UDI
Description
SUSTOL Co-packaged Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00347426101066 FDA UDI
FDA Product Code
FMI FDA UDI
GMDN Term
Syringe-loaded medication/vaccine injector, manual, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Syringe-loaded medication/vaccine injector, manual, professional

SUSTOL Co-packaged Kit by Heron Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Syringe-loaded medication/vaccine injector, manual, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Heron Therapeutics, Inc.

Sources (1)

  • FDA UDI 37d52ccb-5a77-4dfd-af77-43c05a0a7a00 33 fields · synced May 30, 2026