← Back to catalogue

Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Warm-bonded endodontic obturation system obturator FDA UDI
Device Name
OBTURATOR - VER - SIZE 30 Verifier 6 Pack - SIV FDA UDI
Model / Reference
2020348 FDA UDI
Description
OBTURATOR - VER - SIZE 30 Verifier 6 Pack - SIV FDA UDI

Identifiers

Catalog Number
2020348 FDA UDI
Primary DI / UDI-DI
10304040115234 FDA UDI
FDA Product Code
EKM FDA UDI
GMDN Term
Warm-bonded endodontic obturation system obturator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3850 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: Warm-bonded endodontic obturation system obturator

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

Similar devices

Also classified as Warm-bonded endodontic obturation system obturator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI d413ae1d-57d8-41ef-a49d-5973841819de 34 fields · synced Jun 6, 2026