Guide Screw

Basic Information

• Brand Name: Guide Screw
• Primary DI: 14053613292013
• Version / Model: HTZ-2P-040-48
• Catalog Number: HTZ-2P-040-48
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Labeler DUNS: 317409001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-10-12
• Public Version: 1
• Public Version Date: 2024-10-21
• Public Version Status: New
• Public Device Record Key: ee5e2667-f213-4a9f-86cf-262423c8da8a

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66935	Orthopaedic intraoperative positioning pin, single-use	A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24053613292010	GS1		1	In Commercial Distribution
Primary	14053613292013	GS1
Unit of Use	84053613292012	GS1

Premarket Submissions

Submission Number	Supplement Number
K131264	000