Layden Infant Gonio Diagnostic Lens 11.5mm O.D.

GUDID 00630238008129

OCULAR INSTRUMENTS, INC.

Gonioscope

• Primary Device ID: 00630238008129
• NIH Device Record Key: a8c9e20b-d7d2-4a6d-b19e-3d3e8cdac0e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Layden Infant Gonio Diagnostic Lens 11.5mm O.D.
• Version Model Number: OLI-1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630238008129 [Primary]

FDA Product Code

• HKS: Prism, Gonioscopic

Sterilization

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

[00630238008129]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-19
• Device Publish Date: 2019-06-11

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