APX 200 200-300

GUDID 17290017069002

The APX200 is a single patient, single use device, intended to provide expansion of the pupillary aperture.

APX OPHTHALMOLOGY LTD

Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use

• Primary Device ID: 17290017069002
• NIH Device Record Key: 41aa3f3a-f354-47f0-a61f-883f99e8f272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APX 200
• Version Model Number: 200
• Catalog Number: 200-300
• Company DUNS: 600070283
• Company Name: APX OPHTHALMOLOGY LTD
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290017069002 [Primary]
GS1	27290017069009 [Package]; Package: 6 Units Package [6 Units]; In Commercial Distribution
GS1	37290017069006 [Package]; Package: 3 Units Package [3 Units]; In Commercial Distribution

FDA Product Code

• HNQ: Hook, Ophthalmic

Sterilization

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

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

[17290017069002]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-22
• Device Publish Date: 2021-04-14