FN NEEDLES FN18-3T

GUDID 20790986006304

C.P. MEDICAL CORPORATION

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image 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