Vitalitec MI Ball Point Probe

FDA UDI

Class I (US FDA UDI)

by Vitalitec International, Inc.

Identity

Trade Name: Vitalitec MI Ball Point Probe FDA UDI
Generic Name: Stereotactic surgery system probe, reusable FDA UDI
Device Name: Surgical Probe FDA UDI
Model / Reference: MI-7086 FDA UDI
Description: Surgical Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 00850001784580 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Stereotactic surgery system probe, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.4500 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

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 35 Centimeter FDA UDI

Category: Stereotactic surgery system probe, reusable

Vitalitec MI Ball Point Probe by Vitalitec International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Stereotactic surgery system probe, reusable.

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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: Vitalitec International, Inc.

Sources (1)

FDA UDI f53f5dcf-3be4-4053-8059-9afa976e7fd5 35 fields · synced Jun 8, 2026