AccessGUDID - DEVICE: Zida (07297539073145)

GUDID

Device Identifier (DI) Information

Brand Name: Zida
Version or Model: Sock Only, Zida Control Sock Black Extra Large
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7314
Company Name: EXODUS INNOVATION LTD

Primary DI Number: 07297539073145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533132825 *Terms of Use

Device Description: Zida Control Sock Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NAM	Stimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192731	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 26108773-0b22-47b1-a592-667a64a61369
Public Version Date: May 13, 2022
Public Version Number: 1
DI Record Publish Date: May 05, 2022