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Cystosure

FDA UDI

Class II (US FDA UDI)

by Emmy Medical

Identity

Trade Name
Cystosure FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
16Fr Cystosure Plus, 16Fr, silicone catheter FDA UDI
Model / Reference
10-400 FDA UDI
Description
16Fr Cystosure Plus, 16Fr, silicone catheter FDA UDI

Identifiers

Primary DI / UDI-DI
00866403000210 FDA UDI
FDA Product Code
EZL FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Cystosure by Emmy Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Emmy Medical

Sources (1)

  • FDA UDI 4e3f071c-330a-4b3b-ac4e-3cad6dad2b75 35 fields · synced May 30, 2026