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FDA 510(k)

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

K-Number: K183263 · 2019-06-14

ApplicantUnipack Medical Corporation
Decision Date2019-06-14
Product CodePEM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is a medical device manufactured by Unipack Medical Corporation. It received FDA 510(k) clearance on 2019-06-14 under approval number K183263. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope?

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is a medical device that received FDA 510(k) clearance on 2019-06-14. It is manufactured by Unipack Medical Corporation. The 510(k) number is K183263.

When was UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope approved by the FDA?

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope received FDA 510(k) clearance on 2019-06-14, under approval number K183263.

What company makes UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope?

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is manufactured by Unipack Medical Corporation.

What is the FDA product code for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope?

The FDA product code for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is PEM.

Related Devices (Code: PEM)

K160232Disposable Barrier Sleeves and CoversDentsply International, Inc. K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPac-Dent International, Inc. K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited K191448Barrier SleevesIvoclar Vivadent, AG K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. K190949ScanX Barrier EnvelopesAir Techniques, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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