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O-Ring

FDA UDI

Class I (US FDA UDI)

by PREAT Corporation

Identity

Trade Name
O-Ring FDA UDI
Generic Name
Root canal post, preformed FDA UDI
Device Name
O-Ring Metal Retainer #4 FDA UDI
Model / Reference
1500204 FDA UDI
Description
O-Ring Metal Retainer #4 FDA UDI

Identifiers

Catalog Number
1500204 FDA UDI
Primary DI / UDI-DI
00816577024277 FDA UDI
FDA Product Code
EGG FDA UDI
GMDN Term
Root canal post, preformed FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3165 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

O-Ring by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PREAT Corporation

Sources (1)

  • FDA UDI a51a698c-08a8-4fed-a897-53cb8e8cd4bd 36 fields · synced Jun 8, 2026