27G Ultra Short Shielded TotalView Endoillumination Probe, including scleral dep 3269.SBS4S

GUDID 08717872031224

27G Ultra Short Shielded TotalView Endoillumination Probe, including scleral depressor

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

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 08717872031224
• NIH Device Record Key: b386b130-7b01-4e2b-a969-36bacd6ff6da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 27G Ultra Short Shielded TotalView Endoillumination Probe, including scleral dep
• Version Model Number: 3269.SBS4S
• Catalog Number: 3269.SBS4S
• 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	08717872031224 [Primary]
GS1	18717872031221 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190875

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-19
• Device Publish Date: 2019-06-04

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

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