MaxLight® High Mag 78D Slit Lamp Indirect Lens (Gold)

GUDID 00630238083058

OCULAR INSTRUMENTS, INC.

Diagnostic condensing lens

• Primary Device ID: 00630238083058
• NIH Device Record Key: b4b2494d-1f83-42cd-b4c2-230dda18c9f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxLight® High Mag 78D Slit Lamp Indirect Lens (Gold)
• Version Model Number: OI-HM/GD
• 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	00630238083058 [Primary]
GS1	00630238083089 [Direct Marking]

FDA Product Code

• HJL: Lens, Condensing, Diagnostic

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: 2019-06-19
• Device Publish Date: 2019-06-11

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• 00630238006972 - Koeppe Extra Small Diagnostic Lens 12mm O.D.: 2019-06-20
• 00630238007092 - Single Mirror Kaufman Laser Lens: 2019-06-20
• 00630238008075 - Koeppe Large Diagnostic Lens 19mm O.D.: 2019-06-20