Accuject REFRA 2.9 Injector AR2900

GUDID 07630055214850

Medicel AG

Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use

• Primary Device ID: 07630055214850
• NIH Device Record Key: 071f9831-c264-4a88-a32f-f568c3b6292a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accuject REFRA 2.9 Injector
• Version Model Number: REV.P
• Catalog Number: AR2900
• Company DUNS: 487158263
• Company Name: Medicel AG
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630055214850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231106

FDA Product Code

• MSS: Folders And Injectors, Intraocular Lens (Iol)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-12-08

Devices Manufactured by Medicel AG

• 07630055214850 - Accuject REFRA 2.9 Injector: 2023-12-18
• 07630055214850 - Accuject REFRA 2.9 Injector: 2023-12-18
• 07630055240217 - Swiss Coaxial I/A: 2023-12-14 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055242846 - Swiss Bi-Manual I/A: 2023-12-14 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055242853 - Swiss Bi-Manual I/A: 2023-12-14 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055243843 - Swiss Bi-Manual I/A: 2023-12-14 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055243850 - Swiss Bi-Manual I/A: 2023-12-14 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055243881 - Swiss Coaxial I/A: 2023-12-14 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055240026 - Swiss Bi-Manual I/A: 2023-12-11 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.