Clarity® Retractor System 38-STIM

GUDID 00846468049393

Nerve Monitoring Cable, Large

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

• Primary Device ID: 00846468049393
• NIH Device Record Key: 4608abc3-f133-48b5-b0aa-92e2a829b6ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarity® Retractor System
• Version Model Number: 38-STIM
• Catalog Number: 38-STIM
• 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

Customer Support Contacts

• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com
• Phone: 13864188888
• Email: labeling@rtix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468049393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142438

FDA Product Code

• GXZ: Electrode, Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-31
• Device Publish Date: 2018-07-31

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