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PRECISION SPINE, INC. 55-BK-0306 Reform POCT System

Company Name

PRECISION SPINE, INC.

Catalog Number

55-BK-0306

Description

Ø3.5mm Smooth Shank Screw Caddy Kit

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Summary

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DELTA BRANDS INC. Kit Lucky Super Soft

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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TOVA COMPANY, THE Kit T.O.V.A.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

Additional Details

Device Identifier

00840019937092

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

Yes

Is Sterile

No

Is Single Use

No

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	00840019937092