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Steri-Endo Guard Engine

FDA UDI

Class I (US FDA UDI)

by Zirc Dental Products, Inc.

Identity

Trade Name
Steri-Endo Guard Engine FDA UDI
Generic Name
Sterilization packaging, reusable FDA UDI
Device Name
Organizes 11 engines and 5 hand files/reamers. FDA UDI
Model / Reference
N-Neon Blue FDA UDI
Description
Organizes 11 engines and 5 hand files/reamers. FDA UDI

Identifiers

Catalog Number
50Z452N FDA UDI
Primary DI / UDI-DI
D68550Z452N0 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Sterilization packaging, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Category: Sterilization packaging, reusable

Steri-Endo Guard Engine by Zirc Dental Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sterilization packaging, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zirc Dental Products, Inc.

Sources (1)

  • FDA UDI d5262f12-e8a4-443e-b377-676062c0b87b 34 fields · synced Jun 1, 2026