2.4 mm Wise lock Screw, Self tapping, Star Head, 10mm length

Basic Information

• Brand Name: 2.4 mm Wise lock Screw, Self tapping, Star Head, 10mm length
• Primary DI: 08903993318102
• Version / Model: Ti-1145.10
• Company Name: Auxein Medical Private Limited
• Labeler DUNS: 872194615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-02
• Public Version: 1
• Public Version Date: 2022-05-10
• Public Version Status: New
• Public Device Record Key: f4a01b2e-54e9-4dfc-b8bd-4bfa302543eb

Device Description

2.4 mm Wise lock Screw, Self tapping, Star Head, 10mm length

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
65642	Lactoferrin anti-neutrophil cytoplasmic antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) to lactoferrin in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of inflammatory disorders such as rheumatoid vasculitis, ulcerative colitis (UC) and primary sclerosing cholangitis (PSC).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08903993318102	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211324	000