← Product Code [MGQ](/productcode/MGQ) · K962917

# MULTIDEX HYDROPHILIC WOUND DRESSING GEL (K962917)

_Lange Medical Products, Inc. · MGQ · Dec 16, 1996 · SU · SN_

**Canonical URL:** https://fda-staging.innolitics.com/device/K962917

## Device Facts

- **Applicant:** Lange Medical Products, Inc.
- **Product Code:** [MGQ](/productcode/MGQ.md)
- **Decision Date:** Dec 16, 1996
- **Decision:** SN
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Indications for Use

MULTIDEX® Gel in a multi-use container is indicated for the management of stage II, III, IV pressure sores/ulcers, venous stasis ulcers, varicose ulcers, ischemic arterial ulcers, diabetic ulcers, neuropathic ulcers, poorly healing non-neoplastic wounds/ulcers and wounds/ulcers due to trauma.

## Device Story

MULTIDEX Gel; topical wound management agent. Composition: 66.9% Maltodextrin NF, 1% Ascorbic Acid USP, 10% glycerin USP, 22% Purified Water USP, 0.1% sorbic acid. Packaged in 90g low-density polyethylene tube. Applied topically to wounds to facilitate management. Used in clinical settings for various ulcer types.

## Technological Characteristics

Topical gel; ingredients: Maltodextrin NF, Ascorbic Acid USP, glycerin USP, Purified Water USP, sorbic acid. Packaging: 90g low-density polyethylene tube.

## Submission Summary (Full Text)

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DEC 16 1996
K962 917

# ATTACHMENT 3

## 510(K) SUMMARY

MULTIDEX® (polyglucose) Gel contains 66.9 percent Maltodextrin NF, one percent Ascorbic Acid, USP, 10 percent glycerin USP, 22 percent Purified Water USP, and 0.1 percent sorbic acid in a multi-use container.

MULTIDEX® Gel in a multi-use container is indicated for the management of stage II, III, IV pressure sores/ulcers, venous stasis ulcers, varicose ulcers, ischemic arterial ulcers, diabetic ulcers, neuropathic ulcers, poorly healing non-neoplastic wounds/ulcers and wounds/ulcers due to trauma. These are the identical indications as the predicate device.

MULTIDEX Gel in a multi-use container contains the same ingredients as the predicate device with the addition of 0.1 percent sorbic acid as a preservative. It is packaged in a 90 gram low density polyethylene tube.

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**Source:** [https://fda-staging.innolitics.com/device/K962917](https://fda-staging.innolitics.com/device/K962917)

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