Sternal Cable System

GUDID 00846468040765

SS Tapered Cutting Needle, 1 Cable Per Pouch

Pioneer Surgical Technology, Inc.

Internal spinal fixation system cable, sterile

• Primary Device ID: 00846468040765
• NIH Device Record Key: 4747ac66-40ec-4ef6-a61f-de56e0c3870c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sternal Cable System
• Version Model Number: 400-427
• 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	00846468040765 [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