SureCath Set 28029S

• FDA 510(k) K973070 decided 6 Nov 1997 Active
• FDA GUDID UDI-DI 05708932021135 listed 2 Sep 2016 Listed

1. 6 Nov 1997 Cleared FDA 510(k) K973070
2. 2 Sep 2016 Listed FDA GUDID 05708932021135

Trade name

SureCath Set

Generic name

Single-administration urethral catheterization kit, single-use

Model / Ref / Catalog

28029S

Primary DI / UDI-DI

05708932021135

FDA product code

EZD

GMDN term

Single-administration urethral catheterization kit, single-use

Device class

Class II

Regulation number

876.5130

GUDID distribution status

In Commercial Distribution

Size

Catheter Gauge — 16 French

Catheter Working Length — 34 Centimeter

Catheter Working Length — 13.4 Inch

Category: Single-administration urethral catheterization kit, single-use

Other devices filed under FDA product code EZD (CATHETER, STRAIGHT).

• Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus by Convatec, Ltd.
• AMSure®HG Hydrophilic Intermittent Urethral Catheter 1 HG971610SS by AMSINO INTERNATIONAL, INC.
• AMSure® PVC Intermittent Catheter 1 AS860608 by AMSINO INTERNATIONAL, INC.
• Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) by Coloplast Corp.
• COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter by COMPACTCATH, INC
• Mentor Self-Cath Hydrogel Intermittent Catheter by Mentor Corp.
• Busse Hospital Disposables Urethral Catheter by BUSSE HOSPITAL DISPOSABLES
• SpeedCath Compact Male by Coloplast Corp.
• SLIP UROLOGY CATHETER by Percutaneous Systems, Inc.
• COMPACTCATH INTERMITTENT URINARY CATHETER by COMPACTCATH, INC

• Peristeen Plus

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  CE/MDR

• SenSura

  Class I

  CE/MDR

• Alterna

  Class I

  CE/MDR

• SenSura Mio Convex

  Class I

  CE/MDR

See all devices from Coloplast A/S →