SeedLock

GUDID 00813787021294

Prostate Seeding Ndl 1pk Pink EZ (NO PLUG)

THERAGENICS CORPORATION

Brachytherapy needle Brachytherapy needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle

• Primary Device ID: 00813787021294
• NIH Device Record Key: 2beb5f94-60bf-45f7-83a5-93d12498d1b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeedLock
• Version Model Number: PSS1820EZ-1
• Company DUNS: 114379522
• Company Name: THERAGENICS 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813787021294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974118

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

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

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

Ethylene Oxide

[00813787021294]

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: 2016-10-04

On-Brand Devices [SeedLock]

• 00813787021294: Prostate Seeding Ndl 1pk Pink EZ (NO PLUG)
• 00813787021287: Prostate Seeding Needle "SeedLock Pre-Plugged", 1-pack
• 00813787021270: Prostate Seeding Needle "SeedLock Pre-Plugged", 5-pack
• 00813787021263: Prostate Seeding Needle "SeedLock Pre-Plugged", Box 50