Schwert

FDA UDI

Class I (US FDA UDI)

by A. Schweickhardt GmbH & Co. KG

Identity

Trade Name: SCHWERT FDA UDI
Generic Name: Dental surgical probe, reusable FDA UDI
Device Name: OPTIFLEX Plastic perio probe insert Fig. CNC, North Carolina, graduation FDA UDI
Model / Reference: 3409-15 FDA UDI
Description: OPTIFLEX Plastic perio probe insert Fig. CNC, North Carolina, graduation FDA UDI

Identifiers

Catalog Number: 3409-15 FDA UDI
Primary DI / UDI-DI: E8963409150 FDA UDI
FDA Product Code: EIX FDA UDI
GMDN Term: Dental surgical probe, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental surgical probe, reusable

Schwert by A. Schweickhardt GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: A. Schweickhardt GmbH & Co. KG

Sources (1)

FDA UDI e9b59da2-80be-45d5-92bf-4d0197348452 35 fields · synced May 31, 2026