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PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242208

by Primed Medical Products Inc.

Identifiers

510(k) Number
K242208 FDA 510(k)
FDA Product Code
FRG FDA 510(k)
Models / Variants
P100 FDA 510(k)
P200 FDA 510(k)
P300 FDA 510(k)
P400 FDA 510(k)
P500 FDA 510(k)
P600 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PRIMED Sterilization Wrap is a single-use medical device designed to enclose other medical devices during sterilization processes. It is intended for use with pre-vacuum steam sterilization at 270°F/132°C for 4 minutes and with 100% Ethylene Oxide sterilization at 131°F/55°C and 40-80% relative humidity for 60 minutes.

The wrap is available in multiple models (P100, P200, P300, P400, P500, P600) with validated dry times of 20 minutes for P100 and P200, and 30 minutes for P300, P400, P500 and P600. It is manufactured by PRIMED Medical Products Inc. and has received FDA 510(k) clearance with product code FRG. The device is supplied as a single-use product and should be stored according to manufacturer instructions.

Frequently asked questions

What is the PRIMED Sterilization Wrap used for?

The PRIMED Sterilization Wrap is a single-use medical device designed to enclose other medical devices during sterilization processes. It is specifically intended for use with pre-vacuum steam sterilization at 270°F/132°C for 4 minutes and with 100% Ethylene Oxide sterilization at 131°F/55°C and 40-80% relative humidity for 60 minutes.

What are the different models available and their dry times?

The PRIMED Sterilization Wrap is available in multiple models: P100, P200, P300, P400, P500, and P600. Models P100 and P200 have validated dry times of 20 minutes, while models P300, P400, P500, and P600 have validated dry times of 30 minutes.

Is the PRIMED Sterilization Wrap reusable or single-use?

The PRIMED Sterilization Wrap is supplied as a single-use product and should not be reused. It is designed for one-time use during sterilization processes to ensure proper sterilization and prevent cross-contamination between uses.

How should the PRIMED Sterilization Wrap be stored?

The PRIMED Sterilization Wrap should be stored according to the manufacturer's instructions. While specific storage conditions aren't detailed in the provided information, it's generally recommended to store medical wraps in a clean, dry environment away from direct sunlight and extreme temperatures to maintain their integrity until use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sterilization Wraps | Sterilization & Lab | PRIMED Medical Products, Inc., PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K233777 ..., PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Primed Medical Products Inc.
FDA Applicant
Primed Medical Products, Inc.

Sources (1)

  • FDA 510(k) K242208 24 fields · synced Sep 22, 2026