Removal System, Screw, Legacy, Broken & Stripped Extractors MKS1022

Basic Information

• Brand Name: Removal System, Screw, Legacy, Broken & Stripped Extractors MKS1022
• Primary DI: B756TP347M01
• Version / Model: TP347-M01
• Company Name: Shukla Medical
• Labeler DUNS: 159009294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-21
• Public Version: 1
• Public Version Date: 2022-12-29
• Public Version Status: New
• Public Device Record Key: 06799e5f-60ce-435d-bfb1-b1264b8b54d6

Device Description

STRIPPED SCREW TIP M2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HWB	Extractor	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61030	Screw extractor, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B756TP347M01	HIBCC

Customer Contacts

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