Algovita® 5500

GUDID 10821329580427

Torque Wrench

Greatbatch Ltd

Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 10821329580427
• NIH Device Record Key: bc1d0a0a-8749-4431-88c6-d54de4dc5e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Algovita®
• Version Model Number: 5500-USA
• Catalog Number: 5500
• Company DUNS: 968623467
• Company Name: Greatbatch Ltd
• 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: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -35 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821329580420 [Primary]
GS1	10821329580427 [Package]; Contains: 00821329580420; Package: Box [4 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2019-08-23
• Device Publish Date: 2015-12-01

On-Brand Devices [Algovita®]

• 00821329580659: Algovita® Trial 12 Electrode Percutaneous Lead Kit - (standard). Electrode spacing 4 mm.
• 00821329580642: Algovita® Trial 12 Electrode Percutaneous Lead Kit - (compact). Electrode spacing 1 mm.
• 00821329580635: Algovita® Trial 12 Electrode Percutaneous Lead Kit - (standard). Electrode spacing 4 mm.
• 00821329580628: Algovita® Trial 12 Electrode Percutaneous Lead Kit - (compact). Electrode spacing 1 mm.
• 00821329580611: Algovita® Trial 8-Electrode Percutaneous Lead Kit - (Standard). Electrode spacing 4 mm.
• 00821329580604: Algovita® Trial 8-Electrode Percutaneous Lead Kit - (compact). Electrode spacing 1 mm
• 00821329580598: Algovita® Trial 8-Electrode Percutaneous Lead Kit - (Standard). Electrode spacing 4 mm.
• 00821329580581: Algovita® Trial 8-Electrode Percutaneous Lead Kit - (compact). Electrode spacing 1 mm.
• 00821329580574: Trial Cable Lead Marker Kit.
• 00821329580567: Tunneling Tool - Long Length
• 00821329580550: Tunneling Tool - Standard Length
• 00821329580543: Lead Extension 12-Filar (1 X 12)
• 00821329580536: Lead Extension 12-Filar (1 X 12)
• 00821329580529: Lead Extension 12-Filar (1 X 12)
• 00821329580512: Lead Extension 8-Filar (1 X 8)
• 00821329580505: Lead Extension 8-Filar (1 X 8)
• 00821329580499: Lead Extension 8-Filar (1 X 8)
• 00821329580482: Paddle Lead Kit (2 X 6 Electrode Configuration)
• 00821329580475: Paddle Lead Kit (2 X 6 Electrode Configuration)
• 00821329580468: Paddle Lead Kit (3-4-3-2 Electrode Configuration)
• 00821329580451: Paddle Lead Kit (3-4-3-2 Electrode Configuration)
• 00821329580444: Passing Elevator
• 00821329580413: Algovita® Adhesive Anchor Kit.
• 00821329580376: Patient Magnet Kit
• 00821329580369: Trial Simulator Pouch Kit
• 00821329580352: Adhesive Patches Kit
• 00821329580345: Adjustable Belt Kit
• 00821329580338: Programmer Power Cord Kit
• 00821329580314: Patient Feedback Tool (PFT)
• 00821329580307: Patient Programmer / Charger Kit
• 00821329580291: Clinician Programmer (CP)
• 00821329580284: Pocket Programmer (PoP)
• 00821329580277: Trial Stimulator (EPG)
• 00821329580260: Charging Paddle & Cable
• 00821329580253: Algovita® 12 Electrode Percutaneous Lead Kit - (Extended). Electrode spacing 6 mm.
• 00821329580246: Algovita® 12 Electrode Percutaneous Lead Kit - (Extended). Electrode spacing 6 mm.
• 00821329580239: Algovita® 12 Electrode Percutaneous Lead Kit - (Extended). Electrode spacing 6 mm.
• 00821329580222: Algovita® 12 Electrode Percutaneous Lead Kit - (Extended). Electrode spacing 6 mm.
• 00821329580215: Algovita® 12 Electrode Percutaneous Lead Kit - (standard). Electrode spacing 4 mm.
• 00821329580208: Algovita® 12 Electrode Percutaneous Lead Kit - (standard). Electrode spacing 4 mm.
• 00821329580192: Algovita® 12 Electrode Percutaneous Lead Kit - (standard). Electrode spacing 4 mm.
• 00821329580185: Algovita® 12 Electrode Percutaneous Lead Kit - (standard). Electrode spacing 4 mm.
• 00821329580178: Algovita® 12 Electrode Percutaneous Lead Kit - (compact). Electrode spacing 1 mm.
• 00821329580161: Algovita® 12 Electrode Percutaneous Lead Kit - (compact). Electrode spacing 1 mm.
• 00821329580154: Algovita® 12 Electrode Percutaneous Lead Kit - (compact). Electrode spacing 1 mm.
• 00821329580147: Algovita® 12 Electrode Percutaneous Lead Kit - (compact). Electrode spacing 1 mm
• 00821329580130: Algovita® 8-Electrode Percutaneous Lead Kit- (Extended). Electrode spacing 6 mm.
• 00821329580123: Algovita® 8-Electrode Percutaneous Lead Kit - (Extended). Electrode spacing 6 mm.
• 00821329580116: Algovita® 8-Electrode Percutaneous Lead Kit - (Extended). Electrode 6 mm spacing.
• 00821329580109: Algovita® 8-Electrode Percutaneous Lead Kit - (Extended). Electrode spacing 6 mm.