Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth 1285.2

GUDID 08717872004549

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

Therapeutic contact lens

• Primary Device ID: 08717872004549
• NIH Device Record Key: bea72901-cf28-4c31-94ca-1f37d834edc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth
• Version Model Number: 1285.2
• Catalog Number: 1285.2
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	08717872004549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902491

FDA Product Code

• MLP: Keratoprosthesis, Temporary Implant, Surgical Use

Sterilization

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

[08717872004549]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-08
• Device Publish Date: 2016-09-23

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

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