Injex®

Basic Information

• Brand Name: Injex®
• Primary DI: 00763000852887
• Version / Model: 97791
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-19
• Public Version: 2
• Public Version Date: 2025-12-16
• Public Version Status: Update
• Public Device Record Key: fcc3fa41-db91-4b5c-8c22-de8fc594deda

Device Description

ACCESS 97791 INJEX BUMPY ANCHOR EMAN

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: MR Conditional
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGW	Stimulator, spinal-cord, totally implanted for pain relief	Unknown		3
QRB	Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000852887	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P840001	547