Reprocessed Carpal Tunnel Release Blade

GUDID B390810101

SURETEK MEDICAL

Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument

• Primary Device ID: B390810101
• NIH Device Record Key: ee3c5e3d-d409-4079-8740-d9417caef8c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Carpal Tunnel Release Blade
• Version Model Number: 81010
• Company DUNS: 785616934
• Company Name: SURETEK MEDICAL
• 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
HIBCC	B390810101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052692

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

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: 2024-02-02
• Device Publish Date: 2024-01-25

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