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: 1.6mm Mini-Bolt and Cap, Sterile Packaged FDA UDI
Model / Reference: 21165 FDA UDI
Description: 1.6mm Mini-Bolt and Cap, Sterile Packaged FDA UDI

Identifiers

Catalog Number: CMB016-S FDA UDI
Primary DI / UDI-DI: 00816589021561 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

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 1.6 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 04d114e9-ac4d-4d75-915e-53d9610195e5 36 fields · synced Jun 8, 2026