Tritium™* Sternal Cable Plate System 86-30-12-S4

GUDID 00846468061692

Screw, Ø3.0mm X 12mm, 4 Pack

Pioneer Surgical Technology, Inc.

Sternal fixation device

• Primary Device ID: 00846468061692
• NIH Device Record Key: 8a461552-0915-4976-a64d-1f44d49365d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tritium™* Sternal Cable Plate System
• Version Model Number: 86-30-12-S4
• Catalog Number: 86-30-12-S4
• 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	00846468061692 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150581

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: 2015-11-23

On-Brand Devices [Tritium™* Sternal Cable Plate System]

• 00846468066710: SCP Dbl Cable Plate, 64mm Needle
• 00846468063764: SCP Rib Plate
• 00846468061814: Screw, Ø3.0mm X 20mm, 4 Pack
• 00846468061807: Screw, Ø3.0mm X 20mm, 2 Pack
• 00846468061784: Screw, Ø3.0mm X 18mm, 4 Pack
• 00846468061777: Screw, Ø3.0mm X 18mm, 2 Pack
• 00846468061753: Screw, Ø3.0mm X 16mm, 4 Pack
• 00846468061746: Screw, Ø3.0mm X 16mm, 2 Pack
• 00846468061722: Screw, Ø3.0mm X 14mm, 4 Pack
• 00846468061715: Screw, Ø3.0mm X 14mm, 2 Pack
• 00846468061692: Screw, Ø3.0mm X 12mm, 4 Pack
• 00846468061685: Screw, Ø3.0mm X 12mm, 2 Pack
• 00846468061678: Screw, Ø3.0mm X 12mm, 12 Pack
• 00846468061661: Screw, Ø3.0mm X 10mm, 4 Pack
• 00846468061654: Screw, Ø3.0mm X 10mm, 2 Pack
• 00846468061630: Screw, Ø3.0mm X 8mm, 4 Pack
• 00846468061623: Screw, Ø3.0mm X 8mm, 2 Pack
• 00846468061609: Screw, Ø2.7mm X 20mm, 4 Pack
• 00846468061593: Screw, Ø2.7mm X 20mm, 2 Pack
• 00846468061579: Screw, Ø2.7mm X 18mm, 4 Pack
• 00846468049775: SCP, Aux Plate Assy
• 00846468049768: SCP, Box-Plate Assembly
• 00846468049751: SCP, Dbl Cbl Plate Assy