← Product Code [KCT](/productcode/KCT) · K891215

# FAST WRAP #M 101 (K891215)

_Pro-Safe Professional Linens, Inc. · KCT · Apr 14, 1989 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K891215

## Device Facts

- **Applicant:** Pro-Safe Professional Linens, Inc.
- **Product Code:** [KCT](/productcode/KCT.md)
- **Decision Date:** Apr 14, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6850
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

---

**Source:** [https://fda-staging.innolitics.com/device/K891215](https://fda-staging.innolitics.com/device/K891215)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com