visionPRO HyMac 3

GUDID 04053755201556

Heine Optotechnik GmbH & Co. KG

Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use

• Primary Device ID: 04053755201556
• NIH Device Record Key: 9a4e0e8d-b8e7-44d9-b375-b6bcf1cb188f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: visionPRO HyMac 3
• Version Model Number: 000
• Company DUNS: 315274563
• Company Name: Heine Optotechnik GmbH & Co. KG
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053755200900 [Primary]
GS1	04053755201556 [Package]; Contains: 04053755200900; Package: box [10 Units]; In Commercial Distribution
GS1	04053755202072 [Package]; Contains: 04053755200900; Package: box [50 Units]; In Commercial Distribution

FDA Product Code

• CCW: Laryngoscope, Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-20
• Device Publish Date: 2023-07-12

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• 04053755202133 - K180 LED F.O. OTOSCOPE: 2024-07-05
• 04053755202232 - K 180 LED OPHTHALMOSCOPE: 2024-07-05
• 04053755114658 - BETA 200 OTOSCOPE: 2024-06-28 since 2024-05 in LED version: BETA 200 LED F.O. OTOSCOPE
• 04053755114696 - K 180 OTOSCOPE: 2024-06-28 since 2024-05 in LED version: K180 LED OTOSCOPE
• 04053755119981 - BETA 200 OPHTHALMOSCOPE: 2024-06-28 since 2024-05 in LED version: BETA 200 LED OPHTHALMOSCOPE
• 04053755120000 - BETA 200 S OPHTHALMOSCOPE: 2024-06-28 since 2024-05 in LED version: BETA 200S LED OPHTHALMOSCOPE 2.5V