← Product Code [GDY](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDY) · K955322

# PROTEC X-RAY DETECTABLE GAUZE SPONGE (K955322)

_Derivados DE Gasa, S.A. DE C.V. · GDY · Dec 19, 1995 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDY/K955322

## Device Facts

- **Applicant:** Derivados DE Gasa, S.A. DE C.V.
- **Product Code:** [GDY](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDY.md)
- **Decision Date:** Dec 19, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4450
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDY/K955322](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDY/K955322)

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