EVA Cartridge with 0.5 L Collection Bag 8100.CAR01

GUDID 08717872019178

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

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

• Primary Device ID: 08717872019178
• NIH Device Record Key: fdab03b3-3965-4bab-b53d-0b0618669512
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVA Cartridge with 0.5 L Collection Bag
• Version Model Number: 8100.CAR01
• Catalog Number: 8100.CAR01
• 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	08717872019178 [Primary]
GS1	18717872019175 [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: 6
• Public Version Date: 2020-03-19
• Device Publish Date: 2016-09-23

On-Brand Devices [EVA Cartridge with 0.5 L Collection Bag]

• 08717872030623: 8100.CAR11
• 08717872019178: 8100.CAR01