Dynarex ActiSplint

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Dynarex ActiSplint FDA UDI
Generic Name: First aid limb splint, mouldable, reusable FDA UDI
Device Name: Dynarex ActiSplint Rolled 24", Rolled Splint, Breathable, Red/Charcoal Gray FDA UDI
Model / Reference: 3504 FDA UDI
Description: Dynarex ActiSplint Rolled 24", Rolled Splint, Breathable, Red/Charcoal Gray FDA UDI

Identifiers

Primary DI / UDI-DI: 00616784350417 FDA UDI
FDA Product Code: NOC FDA UDI
GMDN Term: First aid limb splint, mouldable, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.3910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: First aid limb splint, mouldable, reusable

Dynarex ActiSplint by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as First aid limb splint, mouldable, reusable.

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ADD-A-SPLINT™ - ANKLE ELBOW — DARCO International, Inc. · Class I
SAM Splint — SAM Medical Products · Class I
SAM Splint — SAM Medical Products · Class I
SAM Soft Shell Splint — SAM Medical Products · Class I
SAM Splint — SAM Medical Products · Class I

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: Dynarex Corp.

Sources (1)

FDA UDI 837acaac-37e0-4409-93a5-59a0b3dcb975 33 fields · synced Jun 6, 2026