CivaDerm P-0296

GUDID 00869497000128

CIVATECH ONCOLOGY, INC.

Manual brachytherapy system

• Primary Device ID: 00869497000128
• NIH Device Record Key: a23deb41-38fc-46f8-b1cd-b3870912b22e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CivaDerm
• Version Model Number: CivaDerm
• Catalog Number: P-0296
• Company DUNS: 801431862
• Company Name: CIVATECH ONCOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869497000128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191324

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

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: 2019-10-21
• Device Publish Date: 2019-10-11

Devices Manufactured by CIVATECH ONCOLOGY, INC.

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