EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure 01.21300.001

GUDID 04030155000392

Kirchner & Wilhelm GmbH + Co KG

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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• 04030155018960 - Children-Prestige stethoscope stainless steel, black: 2024-01-19
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• 04030155000392 - EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure: 2023-09-12
• 04030155000392 - EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure: 2023-09-12