In'Tech Medical 60mm Surgical Illuminator S06 ITM 308

GUDID 00812432021603

LUMITEX, INC.

Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light

• Primary Device ID: 00812432021603
• NIH Device Record Key: 4fd52587-df43-4cb7-ad4c-de28f084fc0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In'Tech Medical 60mm Surgical Illuminator
• Version Model Number: 010810
• Catalog Number: S06 ITM 308
• Company DUNS: 108631797
• Company Name: LUMITEX, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812432021603 [Primary]

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: 2020-10-08
• Device Publish Date: 2020-09-30