LUMIN MIS-100

GUDID H671MIS1000

Laparoscopic Uterine Manipulator-INjector

UTAH MEDICAL PRODUCTS, INC.

Uterine manipulator, single-use

• Primary Device ID: H671MIS1000
• NIH Device Record Key: e0124de3-4fb3-48f7-9a6f-c746c18e98b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIN
• Version Model Number: Uterine Manipulator
• Catalog Number: MIS-100
• Company DUNS: 094651270
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-533-4984
• Email: customer@utahmed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671MIS1000 [Primary]
HIBCC	H671MIS1001 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943448

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

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: 2019-12-24
• Device Publish Date: 2019-12-16

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• H67103001 - DISPOSA-HOOD: 2020-06-12 MEDIUM INFANT HOOD, LARGE NECK
• H67103011 - DISPOSA-HOOD: 2020-06-12 SMALL INFANT HOOD, SMALL NECK
• H67103021 - DISPOSA-HOOD: 2020-06-12 WEIGHTED COLLAR FOR 0300 & 0301 HOODS
• H67103051 - DISPOSA-HOOD: 2020-06-12 LARGE INFANT HOOD, LARGE NECK