Fiber Optic Illuminator

GUDID 10869836000328

I-TEK MEDICAL SOLUTIONS, INC.

Surgical instrument fibreoptic light

• Primary Device ID: 10869836000328
• NIH Device Record Key: 08edcedb-e053-4a4c-9a74-33583566ab7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fiber Optic Illuminator
• Version Model Number: 1102-001
• Company DUNS: 080599644
• Company Name: I-TEK MEDICAL SOLUTIONS, 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: 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: 651-454-6602
• Email: info@i-tekmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869836000321 [Primary]
GS1	10869836000328 [Package]; Contains: 00869836000321; Package: Case [1 Units]; In Commercial Distribution

FDA Product Code

• FDG: Retractor, Fiberoptic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-05
• Device Publish Date: 2019-05-28

On-Brand Devices [Fiber Optic Illuminator]

• 10869836000311: 1136-001
• 00869836000345: 1090-001
• 10869836000328: 1102-001