Mahe Medical USA

Basic Information

• Brand Name: Mahe Medical USA
• Primary DI: 00850078230256
• Version / Model: U-ESR-KS4-AO-S
• Company Name: MAHE MEDICAL USA LLC
• Labeler DUNS: 044831540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-12
• Public Version: 1
• Public Version Date: 2025-09-22
• Public Version Status: New
• Public Device Record Key: aaf4e71d-e8d9-4667-abe4-15300df6c4a5

Device Description

Fully assembled and sterilized Single Pack Stripped Screw 4.5mm-5.5mm

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: Yes
• Has Serial Number: Yes
• 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
HWB	Extractor	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62358	Screw extractor, reusable	A hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850078230256	GS1

Customer Contacts

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