Opal Red

FDA UDI

Class I (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name: Opal Red FDA UDI
Generic Name: Syringe tip cap FDA UDI
Device Name: Opal Red Tips 20 Pack FDA UDI
Model / Reference: 500018- FDA UDI
Description: Opal Red Tips 20 Pack FDA UDI

Identifiers

Catalog Number: 500018- FDA UDI
Primary DI / UDI-DI: 00883205015235 FDA UDI
FDA Product Code: KXR FDA UDI
GMDN Term: Syringe tip cap FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3140 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Syringe tip cap

Opal Red by Ultradent Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Syringe tip cap.

Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC. · Class II
Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC. · Class II
Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC. · Class II
PATTERSON — PATTERSON DENTAL SUPPLY, INC. · Class I
Monoject — Cardinalhealth · Class I
PATTERSON — PATTERSON DENTAL SUPPLY, INC. · Class I
NeoConnect Syringe Tip Cap — NEOMED, INC. · Class II
PATTERSON — PATTERSON DENTAL SUPPLY, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Ultradent Products, Inc.

Sources (1)

FDA UDI f42f5b08-a008-4485-b237-79a66d18a6c9 35 fields · synced Jun 8, 2026