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Henry Schein

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 5722649Model TF-231 (HS)

by Henry Schein Inc.

Identity

Trade Name
Henry Schein EUDAMEDFDA UDI
Generic Name
Dental matrix band, single-use FDA UDI
Device Name
Matrix bands EUDAMED
Tofflemire Matrix Bands.0015 #2 144/Pk FDA UDI
Model / Reference
TF-231 (HS) EUDAMED
5722649 EUDAMEDFDA UDI
Description
Tofflemire Matrix Bands.0015 #2 144/Pk FDA UDI

Identifiers

Catalog Number
5722649 FDA UDI
Primary DI / UDI-DI
10304040121167 EUDAMEDFDA UDI
Basic UDI-DI
03040423101BH EUDAMED
Unit of Use DI
00304040121160 EUDAMED
FDA Product Code
JEP FDA UDI
EMDN Code
Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
GMDN Term
Dental matrix band, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.4565 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein Inc.
EUDAMED SRN
US-MF-000021683
Authorised Representative
Henry Schein Services GmbH DE-AR-000008001

Sources (2)

  • EUDAMED 0ecf8491-be8f-4874-aeb4-555e91f04ea0 61 fields · synced Jul 16, 2026
  • FDA UDI c1c4576a-04ed-4c92-bf17-7e72eda72542 34 fields · synced May 30, 2026