SPECULAR MICROSCOPE

GUDID 04582273603691

TOMEY CORPORATION.

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