SPECULAR MICROSCOPE

GUDID 04582273603691

TOMEY CORPORATION.

Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination

• Primary Device ID: 04582273603691
• NIH Device Record Key: 1169d8b0-ea17-4020-a969-13c4a07e4360
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPECULAR MICROSCOPE
• Version Model Number: EM-4000
• Company DUNS: 696280002
• Company Name: TOMEY CORPORATION.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582273603691 [Primary]
GS1	04582273612822 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171313

FDA Product Code

• NQE: Microscope, Specular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-11
• Device Publish Date: 2022-04-01

On-Brand Devices [SPECULAR MICROSCOPE]

• 04582273612822: EM-4000
• 04582273603691: EM-4000