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 Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic light source Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit

• 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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