DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)

K963188 · Codi International BV · EFQ · Oct 30, 1996 · SU

Device Facts

• Record ID: K963188
• Device Name: DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
• Applicant: Codi International BV
• Product Code: EFQ · SU
• Decision Date: Oct 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

It is intended that the drain/slit sponges will be used as a dressing around tubes and needles and for other general medical and dental purposes for which cotton gauze has traditionally been used.

Device Story

Nonwoven synthetic drain/slit sponge; rayon and polyester fiber construction; slit design accommodates medical tubes or needles; used as wound dressing; provides higher absorbency, lower linting, and reduced wound adhesion compared to traditional cotton gauze; intended for clinical and dental settings; applied by healthcare professionals.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Nonwoven synthetic sponge; rayon and polyester fibers; slit configuration; sterilized via radiation or ethylene oxide; pattern mimics traditional cotton gauze; high absorbency; low linting; low wound adhesion.

Indications for Use

Indicated for use as a dressing around medical tubes and needles, and for general medical and dental applications where traditional cotton gauze is used.

Predicate Devices

• Nu Gauze (Johnson & Johnson Medical, Inc.)
• Versalon (Kendall Co.)

Submission Summary (Full Text)

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OCT 30 1996
K963188

510K SUMMARY

CODI International BV
Turbinestraat 13-19
3903 LV VEENENDAAL
The Netherlands

Telephone: [phone]
Facsimile: 00 31 318 521187

Contact person: Mr. C. van Zwetselaar, Manager of Quality Assurance

August 05, 1996

Trade name of Device: None (to be produced for multiple private labels)
Common Name: Drain/Slit Sponge (Non-Sterile and Sterile)
Classification Name: Synthetic Sponge (Non-Sterile and Sterile) (21 CFR 878.4060)

The products to be manufactured by CODI International BV are non-sterile and sterile versions of a nonwoven synthetic drain/slit sponge that is substantially equivalent to the general use sponges currently produced by CODI International BV for multiple private labels. For other substantially equivalent devices, see general use sponges marketed by Johnson & Johnson Medical, Inc. known as Nu Gauze and general use sponges marketed by Kendall Co. known as Versalon. The drain/slit sponges do not have a different intended use or different technological characteristics than the general use sponges, except that the drain/slit sponges have a slit cut in them to accommodate a tube or needle. The drain/slit sponges are made of rayon and polyester fibers and will be sterilized by radiation or ethylene oxide methods. The finished products have a pattern similar to traditional cotton gauze, but they are softer and more absorbent. The CODI products also have minimal linting and wound adhesion compared to traditional cotton gauze. It is intended that the drain/slit sponges will be used as a dressing around tubes and needles and for other general medical and dental purposes for which cotton gauze has traditionally been used.

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