Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System. 1266.XD

GUDID 08717872001081

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Ophthalmic light source

• Primary Device ID: 08717872001081
• NIH Device Record Key: 4fc6a1c0-ab08-4dca-9788-9c81c44878f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System.
• Version Model Number: 1266.XD
• Catalog Number: 1266.XD
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717872001081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062895

FDA Product Code

• MPA: Endoilluminator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-05-10
• Device Publish Date: 2016-09-23

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