ActiSplint with Sensi-Wrap

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: ActiSplint with Sensi-Wrap FDA UDI
Generic Name: Arm splint system, self-moulding FDA UDI
Device Name: ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wrap; Combo Packs FDA UDI
Model / Reference: 3533 FDA UDI
Description: ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wrap; Combo Packs FDA UDI

Identifiers

Primary DI / UDI-DI: 00616784353333 FDA UDI
FDA Product Code: NOC FDA UDI
KGX FDA UDI
GMDN Term: Arm splint system, self-moulding FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.3910 FDA UDI
880.5240 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: Arm splint system, self-moulding

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

Similar devices

Also classified as Arm splint system, self-moulding.

RTMED — Shandong Haidike Medical Products Co., Ltd. · Class I
RTMED — Shandong Haidike Medical Products Co., Ltd. · 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 f9e1f5e7-645d-45e4-9c14-1f5061b6b583 33 fields · synced Jun 6, 2026