Fiber Optic Light Guide TR9809-11

GUDID 10853480006126

Hardten Iris Retractor Fiber optic light probe with a hooked tip for manipulation and retraction of the iris for optimal visualization of anterior vitreous. 20 ga, with Universal connector. Sterile, single-use.

ESCALON MEDICAL CORP.

Intraocular retractor, single-use

• Primary Device ID: 10853480006126
• NIH Device Record Key: 64a51306-669d-49f8-b082-26a68839968f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fiber Optic Light Guide
• Version Model Number: Iris Retractor, 20 ga
• Catalog Number: TR9809-11
• Company DUNS: 879144426
• Company Name: ESCALON MEDICAL CORP.
• 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

Customer Support Contacts

• Phone: 800-486-4848
• Email: info@escalonmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853480006129 [Primary]
GS1	10853480006126 [Package]; Contains: 00853480006129; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• HNI: Retractor, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-11
• Device Publish Date: 2016-01-14

On-Brand Devices [Fiber Optic Light Guide]

• 10853480006027: Fiber optic light probe for intraocular illumination. Standard light guide, 20 ga, with Univers
• 10853480006126: Hardten Iris Retractor Fiber optic light probe with a hooked tip for manipulation and retraction
• 10853480006119: DCR illuminated fiber optic light probe for transillumination of tissue. 20 ga, with Universal
• 10853480006102: Siepser shielded fiber optic light probe for identifying debris and fibers in the corneal interf
• 10853480006096: Wide angle fiber optic light probe for wide view intraocular illumination. Wide angle light gui
• 10853480006089: Wide angle fiber optic light probe for wide view intraocular illumination. Wide angle light gui
• 10853480006072: Fiber optic light probe for intraocular illumination with tissue manipulation. 45 degree Retina
• 10853480006065: Fiber optic light probe for intraocular illumination with tissue manipulation. 45° Retinal Kni
• 10853480006058: Fiber optic light probe for intraocular illumination with tissue manipulation. 45 ° Light Pick
• 10853480006041: Fiber optic light probe for intraocular illumination with tissue manipulation. 45° Light Pick,
• 10853480006034: Fiber optic light probe for intraocular illumination. Standard light guide, 20 ga, with Trek/Gr