MaxAC® 28D Binocular Indirect Lens

GUDID 00630238077491

OCULAR INSTRUMENTS, INC.

Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens

• Primary Device ID: 00630238077491
• NIH Device Record Key: f888299d-6b22-4b63-bd34-32db25afd31c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxAC® 28D Binocular Indirect Lens
• Version Model Number: OI-28A
• 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	00630238077491 [Primary]
GS1	00630238077545 [Direct Marking]

FDA Product Code

• HJL: Lens, Condensing, Diagnostic

Sterilization

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

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

[00630238077491]

High-level Disinfectant

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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