Shukla Knee S9KNEE

Basic Information

• Brand Name: Shukla Knee S9KNEE
• Primary DI: B756SOS001050
• Version / Model: SOS001-05
• Company Name: Shukla Medical
• Labeler DUNS: 159009294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-13
• Public Version: 1
• Public Version Date: 2021-07-21
• Public Version Status: New
• Public Device Record Key: 70135b83-9ec0-4313-9ba2-e904db8e0e59

Device Description

Osteotome Assy, Retrograde, 1/2" Reach, .313" Wide

Device Characteristics

• Single Use: No
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37837	Orthopaedic osteotome blade, reusable	A sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on one or both sides; it is made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B756SOS001050	HIBCC

Customer Contacts

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