Max360 Three Mirror Small Fissure Lens

GUDID 00630238122214

OCULAR INSTRUMENTS, INC.

Gonioscope Gonioscope

• Primary Device ID: 00630238122214
• NIH Device Record Key: 70d46437-9309-41ba-9a62-1709b408f5d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Max360 Three Mirror Small Fissure Lens
• Version Model Number: OG3MFA-SF-IR
• Company DUNS: 046212387
• Company Name: OCULAR INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630238122214 [Primary]
GS1	00630238122436 [Direct Marking]

FDA Product Code

• HKS: Prism, Gonioscopic

Sterilization

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

[00630238122214]

High-level Disinfectant

[00630238122214]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-07-26

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