Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Henry Schein FDA UDI
Generic Name: Knee support orthosis FDA UDI
Device Name: Knee Brace Hinged 2X FDA UDI
Model / Reference: 5701034 FDA UDI
Description: Knee Brace Hinged 2X FDA UDI

Identifiers

Catalog Number: 5701034 FDA UDI
Primary DI / UDI-DI: 00304040081228 FDA UDI
FDA Product Code: ITW FDA UDI
GMDN Term: Knee support orthosis FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3475 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

Yes

FDA UDI

Convenience Kit

Yes

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: Knee support orthosis

Henry Schein by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MEDI — MEDI MANUFACTURING, INC. · Class I
MEDI — MEDI MANUFACTURING, INC. · Class I
NON FRANCHISE — DJO, LLC · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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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: Henry Schein, Inc.

Sources (1)

FDA UDI a7eb9577-cabc-4362-ae84-fac70cf6ba87 34 fields · synced May 31, 2026