Nevro® ACCK9100

GUDID 00813426020343

Medical Adhesive Kit

NEVRO CORP.

Medical device adhesive, sterile

• Primary Device ID: 00813426020343
• NIH Device Record Key: e3d600f1-d8e0-47c3-81f4-ef84ce4e5422
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nevro®
• Version Model Number: ACCK9100
• Catalog Number: ACCK9100
• Company DUNS: 926599155
• Company Name: NEVRO CORP.
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6502510005
• Email: info@nevro.com
• Phone: 6502510005
• Email: info@nevro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813426020343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130022

FDA Product Code

• LGW: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-05-21

On-Brand Devices [Nevro® ]

• 00813426020428: Surgical Lead Kit, 90cm
• 00813426020404: Surgical Lead Kit, 70cm
• 00813426020398: Surgical Lead Kit, 50cm
• 00813426020381: Trial Lead Kit, 90cm with 5mm spacing
• 00813426020374: Trial Lead Kit, 70cm with 5mm spacing
• 00813426020367: Trial Lead Kit, 50cm with 5mm spacing
• 00813426020343: Medical Adhesive Kit
• 00813426020336: Mx Trial Adaptor Cable Kit
• 00813426020329: Stylet Kit, 90cm Length
• 00813426020312: Stylet Kit, 70cm Length
• 00813426020305: Stylet Kit, 50cm Length
• 00813426020299: Style Kit, 30cm Length
• 00813426020282: IPG Template Kit
• 00813426020275: IPG Port Plug Kit
• 00813426020268: Torque Wrench Kit
• 00813426020251: N300 Lead Anchor Kit
• 00813426020244: N200 Lead Anchor Kit
• 00813426020237: Lead Anchor Kit
• 00813426020220: OR Cable Kit
• 00813426020213: Tunneling Tool Kit, 50cm
• 00813426020206: Tunneling Tool Kit, 35cm
• 00813426020190: Coiled Lead Blank Kit
• 00813426020183: Insertion Needle Kit, 6"
• 00813426020176: Insertion Needle Kit, 4"
• 00813426020145: Programmer Wand Kit
• 00813426020138: Programmer Kit
• 00813426020107: Blue M8 Lead Adaptor Kit, 25cm
• 00813426020091: Blue S8 Lead Adaptor Kit, 25cm
• 00813426020084: Blue Lead Extension Kit, 60cm
• 00813426020077: Blue Lead Extension Kit, 25cm
• 00813426020060: Blue Lead Extension Kit, 35cm
• 00813426020053: Blue Lead Kit, 90cm with 5mm spacing
• 00813426020046: Blue Lead Kit, 70cm with 5mm spacing
• 00813426020039: Blue Lead Kit, 30cm with 5mm spacing
• 00813426020022: Blue Lead Kit, 50cm with 5mm spacing