NA

Basic Information

• Brand Name: NA
• Primary DI: 00841379185253
• Version / Model: DZ8000000
• Catalog Number: DZ8000000
• Company Name: HYHTE HOLDINGS, INC.
• Labeler DUNS: 073029645
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-03
• Public Version: 1
• Public Version Date: 2021-08-11
• Public Version Status: New
• Public Device Record Key: 45f4b599-8a75-4e73-b758-3b189c6ff30a

Device Description

CORPECTOMY CALIPER

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61247	Orthopaedic cement restrictor sizer	A non-sterile, hand-held manual orthopaedic surgical instrument designed to be used to measure the diameter of the medullary canal of a bone (e.g., femur, humerus) in order to select the appropriate size orthopaedic cement restrictor implant. It may be in the form of a trial prosthesis attached to an inserter, or a rod with a measuring gauge at the distal end. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841379185253	GS1

Customer Contacts

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