DMECARE Solutions, Universal Crutches

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: DMECARE Solutions, Universal Crutches FDA UDI
Generic Name: Axillary crutch FDA UDI
Device Name: Split frame design for easy storage, Tool-Free Height adjustments, Fits individuals 4'7" - 6'7". Weight Capacity: 300 LB. FDA UDI
Model / Reference: 10104 FDA UDI
Description: Split frame design for easy storage, Tool-Free Height adjustments, Fits individuals 4'7" - 6'7". Weight Capacity: 300 LB. FDA UDI

Identifiers

Primary DI / UDI-DI: 00616784010410 FDA UDI
FDA Product Code: IPR FDA UDI
GMDN Term: Axillary crutch FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3150 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Axillary crutch

DMECARE Solutions, Universal Crutches by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 59c65428-dfda-44b2-b780-867c6dddc589 33 fields · synced May 30, 2026