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Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical FDA UDI
Generic Name
Intermittent urethral drainage catheter, non-antimicrobial, reusable FDA UDI
Device Name
zenith female catheter, 5-3/4" (14.6 cm), 8 fr. FDA UDI
Model / Reference
UR96282-19 FDA UDI
Description
zenith female catheter, 5-3/4" (14.6 cm), 8 fr. FDA UDI

Identifiers

Catalog Number
UR96282-19 FDA UDI
Primary DI / UDI-DI
G586UR96282190 FDA UDI
FDA Product Code
GCC FDA UDI
GMDN Term
Intermittent urethral drainage catheter, non-antimicrobial, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Intermittent urethral drainage catheter, non-antimicrobial, reusable

Novo Surgical by Novo Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intermittent urethral drainage catheter, non-antimicrobial, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novo Surgical, Inc.

Sources (1)

  • FDA UDI eb77e3ef-f25b-4eaf-8150-8a6533efdf19 35 fields · synced Jun 1, 2026