Fiber Optic Light Guide TR9800-11

GUDID 10853480006027

Fiber optic light probe for intraocular illumination. Standard light guide, 20 ga, with Universal connector. Sterile, single-use

ESCALON MEDICAL CORP.

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 10853480006027
• NIH Device Record Key: 9cb00a3a-eb34-41c9-822f-c3c5b91df274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fiber Optic Light Guide
• Version Model Number: Standard, 20 ga, Universal
• Catalog Number: TR9800-11
• Company DUNS: 879144426
• Company Name: ESCALON MEDICAL CORP.
• 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: 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	00085348006020 [Primary]
GS1	00853480006020 [Primary]
GS1	10853480006027 [Package]; Contains: 00853480006020; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875195

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-31
• Device Publish Date: 2016-01-14

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