Abraham Iridectomy Laser Lens

GUDID 00630238007290

OCULAR INSTRUMENTS, INC.

Laser lens, ophthalmic, surgical Laser lens, ophthalmic, surgical

• Primary Device ID: 00630238007290
• NIH Device Record Key: b367e505-9e15-4826-bc09-e1806b2e52c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abraham Iridectomy Laser Lens
• Version Model Number: OAIY
• 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	00630238007290 [Primary]
GS1	00630238020022 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862713

FDA Product Code

• HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

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

[00630238007290]

High-level Disinfectant

[00630238007290]

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

On-Brand Devices [Abraham Iridectomy Laser Lens]

• 00630238007290: OAIY
• 00630238007016: OAIA