CMI 506TTL

GUDID H671506TTL1

OBSTETRICAL VACUUM DELIVERY KIT, 65mm Ultra Cup, x/ 6' Tube, Adapter, Vacuum Relief Valve

UTAH MEDICAL PRODUCTS, INC.

Foetal vacuum extraction system cup, single-use

• Primary Device ID: H671506TTL1
• NIH Device Record Key: b669daf7-db07-400b-888c-6ef5d71f54bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CMI
• Version Model Number: Ultra Cup
• Catalog Number: 506TTL
• 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 Dimensions

• Lumen/Inner Diameter: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671506TTL0 [Primary]
HIBCC	H671506TTL1 [Package]; Contains: H671506TTL0; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910788

FDA Product Code

• HIS: Condom

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: 2019-12-18
• Device Publish Date: 2016-09-23

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