Glaukos® iprism® (Left-Handed)

GUDID 00630238108201

OCULAR INSTRUMENTS, INC.

Gonioscope

• Primary Device ID: 00630238108201
• NIH Device Record Key: c95d72d9-7ced-48e4-9475-d18c7c2b8e87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glaukos® iprism® (Left-Handed)
• Version Model Number: OTB/LH-2
• 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	00630238108201 [Primary]
GS1	00630238108270 [Direct Marking]

FDA Product Code

• HKS: Prism, Gonioscopic

Sterilization

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

[00630238108201]

Moist Heat or Steam Sterilization

[00630238108201]

Moist Heat or Steam Sterilization

[00630238108201]

Moist Heat or Steam Sterilization

[00630238108201]

Moist Heat or Steam Sterilization

[00630238108201]

Moist Heat or Steam Sterilization

[00630238108201]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-20
• Device Publish Date: 2019-06-12

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