EVA Custom TDC Vitrectomy Pack VGPC Input 27G 8527.402

GUDID 08717872031354

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

Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 08717872031354
• NIH Device Record Key: 65a64633-6d97-4a3c-8e20-aeee65e38fed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVA Custom TDC Vitrectomy Pack VGPC Input 27G
• Version Model Number: 8527.402
• Catalog Number: 8527.402
• 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	08717872031354 [Primary]
GS1	18717872031351 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190875

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2019-11-08
• Device Publish Date: 2019-10-04

On-Brand Devices [EVA Custom TDC Vitrectomy Pack VGPC Input 27G]

• 08717872031354: 8527.402
• 18717872031825: 8527.406
• 18717872032709: 8527.402