Disposable Chandelier fiber (one fiber) incl. guidance needle. (27 gauge/0.4 mm)

GUDID 08717872035574

Disposable Chandelier fiber (one fiber) incl. guidance needle. (27 gauge/0.4 mm)

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

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 08717872035574
• NIH Device Record Key: cbfa2584-c1eb-44bd-8101-158630826869
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Chandelier fiber (one fiber) incl. guidance needle. (27 gauge/0.4 mm)
• Version Model Number: 3269.A27-00
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 6
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08717872035574 [Primary]
GS1	18717872035571 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062895

FDA Product Code

• MPA: Endoilluminator

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

On-Brand Devices [Disposable Chandelier fiber (one fiber) incl. guidance needle. (27 gauge/0.4 mm)]

• 08717872016009: 3269.A27
• 08717872035574: Disposable Chandelier fiber (one fiber) incl. guidance needle. (27 gauge/0.4 mm)