Ritch Trabeculoplasty Laser Lens 712

GUDID 00630238007122

OCULAR INSTRUMENTS, INC.

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• Primary Device ID: 00630238007122
• NIH Device Record Key: c34bda3f-bd2d-4385-bb47-ea4cd3142f46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ritch Trabeculoplasty Laser Lens
• Version Model Number: ORTA
• Catalog Number: 712
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630238007122 [Primary]
GS1	00630238021333 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862512

FDA Product Code

• HKS: Prism, Gonioscopic

Sterilization

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

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

[00630238007122]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-19
• Device Publish Date: 2019-06-12

On-Brand Devices [Ritch Trabeculoplasty Laser Lens]

• 00063023800712: ORTA
• 00630238007122: ORTA