Reprocessed 3.5 Stealth Full Radius Resector

GUDID B390SC92641

3.5mm Orange, Carbon Coated Gator Stealth Blade

SURETEK MEDICAL

Arthroscopic shaver system blade, reprocessed

• Primary Device ID: B390SC92641
• NIH Device Record Key: 25e894ca-8464-4c5e-824b-cdbbe7caeb5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 3.5 Stealth Full Radius Resector
• Version Model Number: SC9264
• Company DUNS: 785616934
• Company Name: SURETEK MEDICAL
• 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
HIBCC	B390SC92641 [Primary]

FDA Product Code

• NBH: Accessories, Arthroscopic

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: 2022-07-04
• Device Publish Date: 2019-08-21

On-Brand Devices [Reprocessed 3.5 Stealth Full Radius Resector]

• B390SC92641: 3.5mm Orange, Carbon Coated Gator Stealth Blade
• B390SC92481: 3.5mm Yellow, Carbon Coated Stealth Full Radius Resector