EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure 01.21300.001

GUDID 04030155000392

Kirchner & Wilhelm GmbH + Co KG

Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope Direct ophthalmoscope

• Primary Device ID: 04030155000392
• NIH Device Record Key: 9dd802c6-6b2b-43ff-a1af-eac4cd9c79e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure
• Version Model Number: 01.21300.001
• Catalog Number: 01.21300.001
• Company DUNS: 315480269
• Company Name: Kirchner & Wilhelm GmbH + Co KG
• 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: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04030155000392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070270

FDA Product Code

• HLJ: Ophthalmoscope, Battery-Powered

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: 2023-09-12
• Device Publish Date: 2023-09-04

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