Anjon Bremer Halo System

FDA UDI

Class II (US FDA UDI)

by Anjon Holdings, LLC

Identity

Trade Name: Anjon Bremer Halo System FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: Anjon Bremer Halo System, Extra Long Halo Skull Pins 2 Sterile FDA UDI
Model / Reference: Extra Long Halo Skull Pins 2 Sterile FDA UDI
Description: Anjon Bremer Halo System, Extra Long Halo Skull Pins 2 Sterile FDA UDI

Identifiers

Catalog Number: 100051 FDA UDI
Primary DI / UDI-DI: 00810592030602 FDA UDI
FDA Product Code: JEC FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

Anjon Bremer Halo System by Anjon Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic bone pin, non-bioabsorbable.

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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 II	Pending data

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Manufacturer

Manufacturer: Anjon Holdings, LLC

Sources (1)

FDA UDI 80ec654d-07f0-46a5-8852-11ccd16f4054 35 fields · synced May 30, 2026