Scleral Buckling Products: Style N/A, 3.75mm Oval Silicone Sleeve 92-36

GUDID 08717872014548

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

Scleral buckling device, non-bioabsorbable

• Primary Device ID: 08717872014548
• NIH Device Record Key: fadf1186-d22d-4380-b9b9-2a11fb3285fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scleral Buckling Products: Style N/A, 3.75mm Oval Silicone Sleeve
• Version Model Number: 92-36
• Catalog Number: 92-36
• 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: 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	08717872014548 [Primary]
GS1	18717872014545 [Package]; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023481

FDA Product Code

• HQX: Implant, Orbital, Extra-Ocular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-12-22
• Device Publish Date: 2015-09-24

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

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