FN NEEDLES FN18-3T

GUDID 20790986006304

C.P. MEDICAL CORPORATION

Imaging lesion localization marker, implantable

• Primary Device ID: 20790986006304
• NIH Device Record Key: 0c714148-0cd0-4f67-96f5-f5fb368bb458
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FN NEEDLES
• Version Model Number: FN18-3T
• Catalog Number: FN18-3T
• Company DUNS: 807404611
• Company Name: C.P. MEDICAL CORPORATION
• 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: false
• 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	10790986006307 [Primary]
GS1	20790986006304 [Package]; Contains: 10790986006307; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071550

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

[20790986006304]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-02-19

On-Brand Devices [FN NEEDLES]

• 20790986006878: FN18-53T
• 20790986006342: FN17-1T
• 20790986006335: FN17-3T
• 20790986006328: FN17-51T
• 20790986006311: FN18-1T
• 20790986006304: FN18-3T
• 20790986006298: FN18-51T