Sternal Cable System

GUDID 00846468040956

Ti Cutting Edge Needle, 4 Cables Per Pouch

Pioneer Surgical Technology, Inc.

Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable

• Primary Device ID: 00846468040956
• NIH Device Record Key: 008bc745-a954-42e4-bbd9-cf30938dafe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sternal Cable System
• Version Model Number: 401-096
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• 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: 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	00846468040956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935481

FDA Product Code

• JDQ: Cerclage, Fixation

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: 2018-07-06
• Device Publish Date: 2017-01-09

On-Brand Devices [Sternal Cable System]

• 00846468053727: SS BLUNT NEEDLE, 64mm, 4 CABLES PER POUCH
• 00846468042264: Instrument Case
• 00846468041182: Ti Two Pack Sternal Crimps
• 00846468041175: Ti BLUNT NEEDLES, 4 CABLES PER POUCH
• 00846468041168: Ti Reverse Cutting Needle, 4 Cables Per Pouch
• 00846468041151: Ti 3 Blunt & 1 Cutting Edge Needle, 4 Cables Per Pouch
• 00846468041144: Ti Tapered Cutting Needle, 4 Cables Per Pouch
• 00846468041076: Crimper/Tensioner
• 00846468041021: SS Blunt Needle, 4 Cables Per Pouch
• 00846468041014: SS 3 Blunt & 1 Cutting Edge Needle, 4 Cables Per Pouch
• 00846468041007: SS Blunt Needle, 1 Cable Per Pouch
• 00846468040956: Ti Cutting Edge Needle, 4 Cables Per Pouch
• 00846468040949: SS 3 Tapered & 1 Reverse Cutting Needle, 4 Cables Per Pouch
• 00846468040925: SS Revers Cutting Needle, 3 Cables Per Pouch
• 00846468040918: SS Cutting Edge Needle, 1 Cable Per Pouch
• 00846468040901: SS Cutting Edge Needle, 3 Cables Per Pouch
• 00846468040895: SS Cutting Edge Needle, 4 Cables Per Pouch
• 00846468040789: INSTRUMENT CASE
• 00846468040772: TENSIONER HANDLE
• 00846468040765: SS Tapered Cutting Needle, 1 Cable Per Pouch
• 00846468040758: SS Tapered Cutting Needle, 4 Cables Per Pouch
• 00846468040741: CRIMPER / TENSIONER
• 00846468040734: SS Reverse Cutting Needle, 1 Cable Per Pouch
• 00846468040727: SS Reverse Cutting Needle, 4 Cables Per Pouch
• 00846468040710: Cable Cutter
• 00846468040697: SS Two Pack Sternal Crimps