GUDID 00813250017540

Sterilizing Case for TCN Electrode

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Radio-frequency ablation system

• Primary Device ID: 00813250017540
• NIH Device Record Key: bddb6737-dc9a-41cd-a3a4-ce93e251513c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TCN-CASE
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00813250017540 [Primary]

FDA Product Code

• GXI: PROBE, RADIOFREQUENCY LESION

Sterilization

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

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

[00813250017540]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-08
• Device Publish Date: 2017-08-21

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

• 08714729888734 - Precision™: 2024-09-24 M8 Adapter, 15cm
• 08714729888758 - Precision™: 2024-09-24 M8 Adapter, 55cm
• 08714729893271 - Precision™: 2024-09-24 S8 Adapter, 15cm
• 08714729893288 - Precision™: 2024-09-24 S8 Adapter, 55cm
• 08714729897804 - NA: 2024-08-21 Installer for BN3.1
• 08714729897811 - NA: 2024-08-21 Clinician Programmer
• 08714729897835 - Precision Novi™: 2024-08-21 Implantable Pulse Generator Kit
• 08714729897873 - NA: 2024-08-21 Clinican Programmer (Refurbished)