Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4 3269.D04

GUDID 08717872018577

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

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 08717872018577
• NIH Device Record Key: a120dc5e-f5fc-4f6c-b186-8972e53ceea4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4
• Version Model Number: 3269.D04
• Catalog Number: 3269.D04
• 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	08717872018577 [Primary]
GS1	18717872018574 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-23

On-Brand Devices [Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4]

• 08717872018577: 3269.D04
• 08717872029832: 3269.D04