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Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Orthodontic appliance relief material FDA UDI
Device Name
ARCHWIRE SLEEVES GREY .018 FDA UDI
Model / Reference
1063042 FDA UDI
Description
ARCHWIRE SLEEVES GREY .018 FDA UDI

Identifiers

Catalog Number
1063042 FDA UDI
Primary DI / UDI-DI
00304040117910 FDA UDI
FDA Product Code
ECI FDA UDI
GMDN Term
Orthodontic appliance relief material FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5410 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthodontic appliance relief material

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

Similar devices

Also classified as Orthodontic appliance relief material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 9f0aaaea-d836-4e47-b828-7c79d09f8982 34 fields · synced May 30, 2026