SLING, KNEE, KODEL

Basic Information

• Brand Name: SLING, KNEE, KODEL
• Primary DI: 00842430112690
• Version / Model: 334
• Catalog Number: 334
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-30
• Public Version: 1
• Public Version Date: 2020-10-08
• Public Version Status: New
• Public Device Record Key: 41e43ef0-bd06-4174-bf08-c3fc2e81e2c7

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSP	Splint, Traction	Orthopedic	888.5890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13623	Knee sling	A hanging band, typically suspended from an overhanging structure, intended to be used to cradle a knee to support and limit the range of motion of an injured knee/leg during healing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430112690	GS1

Customer Contacts

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