G100 G-001.21.301

GUDID 04053755131501

since 2024-05 in LED version

Heine Optotechnik GmbH & Co. KG

Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct 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

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• 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
• 04053755120017 - K 180 OPHTHALMOSCOPE: 2024-06-28 since 2024-05 in LED version: K180 LED ophthalmoscope
• 04053755131488 - BETA 200 VET. OTOSCOPE: 2024-06-28 since 2024-05 in LED version: BETA 200 LED VET. OTOSCOPE
• 04053755131501 - G100: 2024-06-28since 2024-05 in LED version
• 04053755131501 - G100: 2024-06-28 since 2024-05 in LED version
• 04053755179718 - BETA 400 OTOSCOPE: 2024-06-28 since 2024-05 in LED version: BETA 400 LED OTOSCOPE