Mini-Bolt System

FDA UDI

Class I (US FDA UDI)

by Monteris Medical Corp

Identity

Trade Name: Mini-Bolt System FDA UDI
Generic Name: Neurological stereotactic surgery system FDA UDI
Device Name: 3.3mm x 8mm x 5mm Hex Driver SR FDA UDI
Model / Reference: 20816 FDA UDI
Description: 3.3mm x 8mm x 5mm Hex Driver SR FDA UDI

Identifiers

Catalog Number: 20816 FDA UDI
Primary DI / UDI-DI: 00816589021523 FDA UDI
FDA Product Code: HAO FDA UDI
GMDN Term: Neurological stereotactic surgery system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 882.4535 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.3 Millimeter FDA UDI

Category: Neurological stereotactic surgery system

Mini-Bolt System by Monteris Medical Corp — 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: Monteris Medical Corp

Sources (1)

FDA UDI 7ede2a17-3a65-493e-9d1b-1ef45579ad4a 37 fields · synced Jun 1, 2026