PURE KIT

Basic Information

• Brand Name: PURE KIT
• Primary DI: 03760177045217
• Version / Model: T060425
• Company Name: TEKNIMED
• Labeler DUNS: 764746723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-03
• Public Version: 1
• Public Version Date: 2022-05-11
• Public Version Status: New
• Public Device Record Key: d386bd15-ee01-4290-8a15-8cfbc44c6c90

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: No
• 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
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	888.4200	1
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	888.4210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45253	Orthopaedic cement preparation/delivery kit	A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760177045217	GS1