Anjon Bremer Halo System

Basic Information

• Brand Name: Anjon Bremer Halo System
• Primary DI: 00810592030596
• Version / Model: Cutting Tip Halo Skull Pins 5 Sterile
• Catalog Number: 100052
• Company Name: ANJON HOLDINGS LLC
• Labeler DUNS: 080902221
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-01
• Public Version: 2
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 49bfa4ef-3fee-4c08-9ffa-90ca85e9ecb4

Device Description

Anjon Bremer Halo System, Cutting Tip Halo Skull Pins 5 Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEC	Component, Traction, Invasive	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810592030596	GS1
Package	10810592030593	GS1	15 PACK BOX	15	In Commercial Distribution
Package	20810592030590	GS1	3 BOX SHIPPER	45	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]