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
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• 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

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[04049539101594]

Moist Heat or Steam Sterilization

[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

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