Stradis Medical, LLC.

FDA UDI

Class II (US FDA UDI)

by Stradis Medical, Llc

Identity

Trade Name: Stradis Medical, LLC. FDA UDI
Generic Name: Wound dressing kit, non-medicated FDA UDI
Device Name: Dressing Change Tray FDA UDI
Model / Reference: IM1256 FDA UDI
Description: Dressing Change Tray FDA UDI

Identifiers

Primary DI / UDI-DI: M752IM12560 FDA UDI
FDA Product Code: MCY FDA UDI
GMDN Term: Wound dressing kit, non-medicated FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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Single Use

Yes

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Implantable

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

Yes

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

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Category: Wound dressing kit, non-medicated

Dressing Change Trays for Wound Dressing Kits, providing a convenient and hygienic way to change wound dressings. This tray features multiple compartments and can be easily assembled and disassembled, making it ideal for use in various medical settings.

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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 II	Pending data

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Manufacturer

Manufacturer: Stradis Medical, Llc

Sources (1)

FDA UDI 52611eda-46df-4a64-8032-66a0b3042c75 34 fields · synced Jul 23, 2026