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ARTHREX, INC. ABS-10062D Arthrex®

Company Name

ARTHREX, INC.

Catalog Number

ABS-10062D

Description

Angel System w/ Pwr Aspiration Kit wACDA

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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

00888867258112

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

Yes

Is Single Use

Yes

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	00888867258112
Each	1	M150ABS10062D1