Rigid Shield 7 cm

FDA UDI

Class II (US FDA UDI)

by Icad, Inc.

Identity

Trade Name: Rigid Shield 7 cm FDA UDI
Generic Name: Radiation shielding apron FDA UDI
Device Name: Rigid Shield 7 cm FDA UDI
Model / Reference: 710710 FDA UDI
Description: Rigid Shield 7 cm FDA UDI

Identifiers

Catalog Number: F5350-7 FDA UDI
Primary DI / UDI-DI: 00858012005403 FDA UDI
510(k) Number: K111299 FDA UDI
FDA Product Code: JAD FDA UDI
GMDN Term: Radiation shielding apron FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5900 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Radiation shielding apron

Rigid Shield 7 cm by Icad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K111299 also covers:

Axxent Radiation Shield - Rigid — Icad, Inc.
Rigid Shield 3 cm — Icad, Inc.
Rigid Shield 4 cm — Icad, Inc.
Rigid Shield 5 cm — Icad, Inc.
Rigid Shield 6 cm — Icad, Inc.

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: Icad, Inc.

Sources (1)

FDA UDI 0f72e4ea-8375-4ef7-bf9f-88f85f6e81f9 35 fields · synced May 30, 2026