G100 G-001.21.301

GUDID 04053755131501

since 2024-05 in LED version

Heine Optotechnik GmbH & Co. KG

Otoscope, direct

• Primary Device ID: 04053755131501
• NIH Device Record Key: 415c609c-68c3-46fb-9f59-04ac5d4b307f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G100
• Version Model Number: 2,5 V
• Catalog Number: G-001.21.301
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053755131501 [Primary]

FDA Product Code

• ERA: Otoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-06-28
• Device Publish Date: 2022-12-21

Devices Manufactured by Heine Optotechnik GmbH & Co. KG

• 04053755136988 - GAMMA 3.1: 2024-11-25
• 04053755136995 - GAMMA 3.2: 2024-11-25
• 04053755137015 - GAMMA 3.3: 2024-11-25
• 04053755137039 - GAMMA C.3: 2024-11-25
• 04053755179206 - BETA 400 LED F.O. OTOSCOPE: 2024-08-14
• 04053755201853 - visionPRO Mac 2: 2024-08-14
• 04053755202423 - MINI3000 LED OTOSCOPE: 2024-08-14 available also in blue
• 04053755202508 - BETA 200 LED RETINOSCOPE: 2024-07-24