Kobold® Prostate HDR Template - 16 ga/5 Fr

GUDID 00815568020090

KOBOLD, LLC

Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use

• Primary Device ID: 00815568020090
• NIH Device Record Key: 99ff3e68-ac52-4eae-b326-7311c95cda02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kobold® Prostate HDR Template - 16 ga/5 Fr
• Version Model Number: 802-000
• Company DUNS: 014292258
• Company Name: KOBOLD, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• 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	00815568020090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170203

FDA Product Code

• JAQ: System, Applicator, Radionuclide, Remote-Controlled

Sterilization

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

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

[00815568020090]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-07-18

On-Brand Devices [Kobold® Prostate HDR Template - 16 ga/5 Fr]

• 00815568020090: 802-000
• 00815568021264: Labelled with CE