Kobold® Prostate HDR Stepper Template - 6 Fr

GUDID 00815568020892

Labelled with CE

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 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: 00815568020892
• NIH Device Record Key: 3ce5d219-3984-48be-b9f7-e4bf9092e585
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kobold® Prostate HDR Stepper Template - 6 Fr
• Version Model Number: 813-000
• 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	00815568020892 [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

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

[00815568020892]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-17
• Device Publish Date: 2019-12-09

Devices Manufactured by KOBOLD, LLC

• 00815568020892 - Kobold® Prostate HDR Stepper Template - 6 Fr: 2019-12-17Labelled with CE
• 00815568020892 - Kobold® Prostate HDR Stepper Template - 6 Fr: 2019-12-17 Labelled with CE
• 00815568020922 - Kobold® Henschke-model Tandem and Ovoid Applicator Set (E): 2019-12-16 Labelled with CE mark
• 00815568020977 - Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E): 2019-12-16 Labelled with CE mark
• 00815568020984 - Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E): 2019-12-16 Labelled with CE mark
• 00815568020991 - Kobold® Vaginal Cylinder Applicator Set (E): 2019-12-16 Labelled with CE mark
• 00815568020007 - Kobold® Henschke-model Tandem and Ovoid Applicator Set (E): 2019-12-16
• 00815568020014 - Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E): 2019-12-16
• 00815568020021 - Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E): 2019-12-16