Precision™

GUDID 08714729888765

M8 Trial Adapter, 55cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable electrical stimulation system intraoperative test lead

• Primary Device ID: 08714729888765
• NIH Device Record Key: 3a3f4baf-dbaf-4447-bcbf-47151efe7b9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision™
• Version Model Number: SC-9218-55E
• 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: true
• Lot Batch: true
• Serial Number: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729888765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-20
• Device Publish Date: 2015-12-14

On-Brand Devices [Precision™]

• 08714729837138: Implantable Pulse Generator Kit
• 08714729767688: Implantable Pulse Generator Kit
• 08714729121695: Remote Control
• 08714729821519: Implantable Pulse Generator and Charger Kit
• 08714729820734: Patient Programmer Kit
• 08714729767657: IRDA Dongle Holder
• 08714729121589: IPG Port Plug
• 08714729121435: Hex Wrench
• 08714729893301: S8 Trial Adapter, 55cm
• 08714729893295: S8 Trial Adapter, 15cm
• 08714729888765: M8 Trial Adapter, 55cm
• 08714729888741: M8 Trial Adapter, 15cm
• 08714729821243: Charging System Kit
• 08714729121763: PC SC-7150
• 08714729893288: S8 Adapter, 55cm
• 08714729893271: S8 Adapter, 15cm
• 08714729888758: M8 Adapter, 55cm
• 08714729888734: M8 Adapter, 15cm