DEVICE: Wizard Wand (00850013958122)

Device Identifier (DI) Information

Wizard Wand
WW-01
In Commercial Distribution

C F M TECHNOLOGIES INC
00850013958122
GS1

1
040748944 *Terms of Use
Wizard Wand Professional Eye Care Set. This kit contains a versatile set of components designed to facilitate effective examination of the eyes for foreign bodies and corneal abrasions and removal of foreign bodies from the conjunctiva.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
33737 Corneal staining strip
A small absorbent strip, made of filter paper or similar material, which is impregnated with a small amount of a chemical (e.g., fluorescein sodium, lissamine green) intended to be applied to the cornea to function as a dye for ophthalmic examinations of the anterior segment of the eye. It is typically used to stain the cornea when fitting contact lenses, to disclose corneal injury (e.g., to enhance superficial abrasions for examination), in applanation tonometry, or evaluation of dry eye syndrome. This is a single-use device.
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46718 Eye magnet, non-powered
A non-electric hand-held instrument designed to generate a magnetic field intended to locate and remove metallic foreign bodies [typically those containing iron (Fe) or steel] from eye tissue; it may include a wire loop at one end for mechanical extraction. This is a reusable device.
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45085 ENT diagnostic set
A collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HPN Magnet, Permanent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

eda3964d-1fa3-4b89-ae08-01d990800a3b
February 06, 2020
2
January 06, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
Yes
No
No CLOSE

Customer Contact

[?]
6039243751
cfm@cfmtechnologies.com
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