Zida

Basic Information

• Brand Name: Zida
• Primary DI: 07297539082154
• Version / Model: Control Sock Black Large
• Catalog Number: 8215
• Company Name: EXODUS INNOVATION LTD
• Labeler DUNS: 533132825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-03
• Public Version: 2
• Public Version Date: 2022-05-05
• Public Version Status: Update
• Public Device Record Key: 50dd06e2-240c-43ac-b238-13338b277477

Device Description

Zida Control Sock Kit

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
NAM	Stimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction	Gastroenterology, Urology	876.5310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36175	Sacral plexus implantable incontinence-control electrical stimulation system	An assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder. It consists of an electrode implanted on or in the vicinity of the sacral plexus, a pulse generator with a receiver typically implanted in the abdomen/pelvic region, and an external programmer/transmitter that communicates with the implanted receiver.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07297539082154	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192731	000