Tritium Sternal Cable Plate System 86-PLTCUTTER-3

GUDID 00846468080495

Plate Cutter

Pioneer Surgical Technology, Inc.

Sternal fixation device

• Primary Device ID: 00846468080495
• NIH Device Record Key: 072fbb30-9548-4633-a33c-94c5e24d26ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tritium Sternal Cable Plate System
• Version Model Number: 86-PLTCUTTER-3
• Catalog Number: 86-PLTCUTTER-3
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	00846468080495 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

[00846468080495]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-27

On-Brand Devices [Tritium Sternal Cable Plate System]

• 00846468080501: Cable Cutter
• 00846468080495: Plate Cutter
• 00191083005539: Box Plate Without Cable
• 00191083005522: X Plate Without Cable