Cohere

Basic Information

• Brand Name: Cohere
• Primary DI: 00887517017574
• Version / Model: 1814364
• Company Name: Nuvasive, Inc.
• Labeler DUNS: 053950783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-14
• Public Version: 2
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: 0ded969c-dc88-49f3-a858-125676843020

Device Description

COHERE TLIF-A Inserter

Device Characteristics

• Single Use: No
• 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
PHM	Intervertebral fusion device with bone graft, thoracic	Orthopedic	888.3080	2
MAX	Intervertebral fusion device with bone graft, lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16349	Instrument transport trolley system	A combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887517017574	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181860	000