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Zida

FDA UDI

Class II (US FDA UDI)

by Exodus Innovation Ltd

Identity

Trade Name
Zida FDA UDI
Generic Name
Sacral plexus implantable incontinence-control electrical stimulation system FDA UDI
Device Name
Zida Control Sock, Sock Only FDA UDI
Model / Reference
Sock Only, Zida Control Sock Black Medium FDA UDI
Description
Zida Control Sock, Sock Only FDA UDI

Identifiers

Catalog Number
7116 FDA UDI
Primary DI / UDI-DI
07297539071165 FDA UDI
510(k) Number
K192731 FDA UDI
FDA Product Code
NAM FDA UDI
GMDN Term
Sacral plexus implantable incontinence-control electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Sacral plexus implantable incontinence-control electrical stimulation system

Zida by Exodus Innovation Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacral plexus implantable incontinence-control electrical stimulation system.

Cleared under the same submission

K192731 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exodus Innovation Ltd

Sources (1)

  • FDA UDI a49de24b-7d80-4b98-9f86-171c1a1c8629 36 fields · synced May 30, 2026