Precision Novi™ SC-1140

GUDID 08714729897835

Implantable Pulse Generator Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

• Primary Device ID: 08714729897835
• NIH Device Record Key: f19d1890-071a-4ffa-a523-af14cd6035c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Novi™
• Version Model Number: SC-1140
• Catalog Number: SC-1140
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08714729897835 [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: true
• Device Is Sterile: true

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

[08714729897835]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-21
• Device Publish Date: 2015-09-04

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