Mandelkorn Iridotomy-Capsulotomy Laser Lens

GUDID 00630238056007

OCULAR INSTRUMENTS, INC.

Laser lens, ophthalmic, surgical

• Primary Device ID: 00630238056007
• NIH Device Record Key: 39afb52b-e783-4ec6-af50-222ec2251cdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mandelkorn Iridotomy-Capsulotomy Laser Lens
• Version Model Number: OMIC
• Company DUNS: 046212387
• Company Name: OCULAR INSTRUMENTS, INC.
• 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: 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	00630238055970 [Direct Marking]
GS1	00630238056007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872136

FDA Product Code

• HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

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

[00630238056007]

High-level Disinfectant

[00630238056007]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-12-12

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