CivaSheet

GUDID 00869497000111

CIVATECH ONCOLOGY, INC.

Manual brachytherapy source, permanent implant

• Primary Device ID: 00869497000111
• NIH Device Record Key: 3cf09694-9a09-4071-a787-acbed8571217
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CivaSheet
• Version Model Number: CivaSheet
• Company DUNS: 801431862
• Company Name: CIVATECH ONCOLOGY, INC.
• 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: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Device is stored according to the users Radioactive Material Licence

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869497000111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140490

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-16

Devices Manufactured by CIVATECH ONCOLOGY, INC.

• 00869497000128 - CivaDerm: 2019-10-21
• 00869497000104 - CivaString: 2018-07-06
• 00869497000111 - CivaSheet: 2018-07-06
• 00869497000111 - CivaSheet: 2018-07-06