INTRABEAM® Spherical Applicator 3.0 cm

GUDID 04049539101594

Carl Zeiss Meditec AG

Intraoperative/postoperative therapeutic x-ray system spherical applicator

• Primary Device ID: 04049539101594
• NIH Device Record Key: a92de92c-70ec-4bfa-9ed8-52a711e2f1c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRABEAM® Spherical Applicator 3.0 cm
• Version Model Number: 304534-6000-560
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 3 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049539101594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121653

FDA Product Code

• JAD: System, Therapeutic, X-Ray

Sterilization

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

[04049539101594]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-14

Devices Manufactured by Carl Zeiss Meditec AG

• 04049471095074 - MEL 90: 2024-12-23 The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue ac
• 04049471095111 - VISUMAX: 2024-12-23 The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in th
• 04049539106704 - Single-use lenses for RESIGHT, MACULA LENS: 2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
• 04049539106735 - Single-use lenses for RESIGHT, WIDE-ANGLE LENS: 2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
• 04049539106766 - Single-use lenses for RESIGHT, ULTRA WIDE-ANGLE LENS: 2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
• 04049539064097 - KINEVO 900 S: 2024-10-15
• 04049539070159 - BLUE 400: 2024-10-15 accessory for surgical microscopes
• 04049539070166 - YELLOW 560: 2024-10-15 accessory for surgical microscopes