Tendon Stabilizing Guide 4402

GUDID 00854501006166

ROTATION MEDICAL, INC.

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• Primary Device ID: 00854501006166
• NIH Device Record Key: 71371622-6503-4e50-9119-28290b7563e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tendon Stabilizing Guide
• Version Model Number: 4402
• Catalog Number: 4402
• Company DUNS: 031098401
• Company Name: ROTATION MEDICAL, 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: 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	00854501006166 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-09

Devices Manufactured by ROTATION MEDICAL, INC.

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• 00854501006159 - Bone Anchors with Arthroscopic Delivery System - Advanced: 2019-03-21
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