ShadowForm Marker

FDA UDI

Class II (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: ShadowForm Marker FDA UDI
Generic Name: Radiographic image marker, manual FDA UDI
Model / Reference: VIP1710 FDA UDI

Identifiers

Primary DI / UDI-DI: 00815212021695 FDA UDI
510(k) Number: K964972 FDA UDI
FDA Product Code: KPQ FDA UDI
GMDN Term: Radiographic image marker, manual FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5840 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Radiographic image marker, manual

ShadowForm Marker by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K964972 also covers:

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: Izi Medical Products Llc

Sources (1)

FDA UDI 7fc37de6-cd26-4ee0-8b2f-2bcd8a7689c0 33 fields · synced May 30, 2026