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STRADIS MEDICAL, LLC UPK-200 Stradis Medical, LLC.

Company Name

STRADIS MEDICAL, LLC

Catalog Number

UPK-200

Description

Universal Precaution Kit

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Pricing
Summary

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First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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Additional Details

Device Identifier

M752UPK2001

Is RX

No

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

No

Is Single Use

Yes

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	M752UPK2001
Outer Box of 25	25	M752UPK2005