CoreTech

FDA UDI

Class I (US FDA UDI)

by Vive Health Llc

Identity

Trade Name: CoreTech FDA UDI
Generic Name: Shoulder immobilizer/orthosis, reusable FDA UDI
Device Name: Humeral Fracture Splint FDA UDI
Model / Reference: SUP3015BLK FDA UDI
Description: Humeral Fracture Splint FDA UDI

Identifiers

Primary DI / UDI-DI: 00810113570617 FDA UDI
FDA Product Code: IQQ FDA UDI
GMDN Term: Shoulder immobilizer/orthosis, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3420 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: Shoulder immobilizer/orthosis, reusable

CoreTech by Vive Health Llc — 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: Vive Health Llc

Sources (1)

FDA UDI 8c57f389-34df-43f1-9a20-51d208ac0dc3 33 fields · synced Jun 1, 2026