AnchorMarker

GUDID 00813787021195

4.5mm AnchorMarker, 1-pk

THERAGENICS CORPORATION

Imaging lesion localization marker, implantable

• Primary Device ID: 00813787021195
• NIH Device Record Key: d9c2cebe-ac97-45b3-bbfa-0e8b1199adeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnchorMarker
• Version Model Number: AM0845SL3-1
• Company DUNS: 114379522
• Company Name: THERAGENICS CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813787021195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083274

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

[00813787021195]

Ethylene Oxide

Device Entry Metadata

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

On-Brand Devices [AnchorMarker]

• 00813787021201: 4.5mm AnchorMarker, 3-pk
• 00813787021195: 4.5mm AnchorMarker, 1-pk