Diagnostix™ 5680B-3EU

GUDID 00634782091132

Adstation Oto+-X/Coax Oph-L,Spec Disp, EU

AMERICAN DIAGNOSTIC CORP

Ophthalmic/otologic diagnostic set

• Primary Device ID: 00634782091132
• NIH Device Record Key: dbbbd8ca-79c9-4bfd-ba75-46546a639004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diagnostix™
• Version Model Number: 5680B-3EU
• Catalog Number: 5680B-3EU
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782091132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950914

FDA Product Code

• ERA: Otoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-09

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• 00634782093716: Adstation Oto+-X ,Throat-X, EU
• 00634782093709: Adstation Oto+-X ,Throat-X, Clock Aner, EU
• 00634782093693: Adstation Oto+-X ,Throat-X, Clock Aner
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• 00634782093679: Adstation Oto+-X ,Throat-L, EU
• 00634782093662: Adstation Oto+-X ,Throat-L, Clock Aner, EU
• 00634782093655: Adstation Oto+-X ,Throat-L, Clock Aner
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• 00634782093631: Adstation Oto+-X ,Derm, EU
• 00634782093624: Adstation Oto+-X ,Derm, Clock Aner, EU
• 00634782093617: Adstation Oto+-X ,Derm, Clock Aner
• 00634782093600: Adstation Oto+-X ,Derm, Throat-X, EU
• 00634782093594: Adstation Oto+-X ,Derm, Throat-X
• 00634782093587: Adstation Oto+-X ,Derm, Throat-L, EU
• 00634782093570: Adstation Oto+-X ,Derm, Throat-L
• 00634782093563: Adstation Oto+-X ,Derm
• 00634782093556: Adstation Oto+-X ,Spec Disp, EU
• 00634782093549: Adstation Oto+-X ,Clock Aner, Spec Disp, EU
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• 00634782093525: Adstation Oto+-X ,Throat-X, Spec Disp, WB
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• 00634782093488: Adstation Oto+-X/Throat-X,9005W/Spec Disp, WB, EU
• 00634782093471: Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, WB
• 00634782093464: Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, EU, WB
• 00634782093457: Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, EU
• 00634782093440: Adstation Oto+-X ,Throat-X, Clock Aner/Spec Disp
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• 00634782093419: Adstation Oto+-X ,Throat-L, Spec Disp, EU, WB
• 00634782093402: Adstation Oto+-X ,Throat-L, Spec Disp, EU
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• 00634782093327: Adstation Oto+-X ,Derm, Spec Disp, WB
• 00634782093310: Adstation Oto+-X ,Derm, Spec Disp, EU, WB
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