Quantum MIS Cannulated System 51-STIM-1

GUDID 00846468050535

Nerve Monitoring Cable

Pioneer Surgical Technology, Inc.

Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor Nerve-function monitor

• Primary Device ID: 00846468050535
• NIH Device Record Key: b3f68720-27b3-46d8-a516-7889b1f37660
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum MIS Cannulated System
• Version Model Number: 51-STIM-1
• Catalog Number: 51-STIM-1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468050535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073229

FDA Product Code

• ETN: STIMULATOR, NERVE

Sterilization

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

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

[00846468050535]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

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