Reprocessed 5mm Hoodless Sheath, Oval Tapered

GUDID B390AR8500HSO1

SURETEK MEDICAL

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• Primary Device ID: B390AR8500HSO1
• NIH Device Record Key: ad373ad8-2f1b-452c-a7bc-d8788115bde4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 5mm Hoodless Sheath, Oval Tapered
• Version Model Number: AR-8500HSO
• 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	B390AR8500HSO1 [Primary]

FDA Product Code

• NBH: Accessories, Arthroscopic

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: 2022-05-03
• Device Publish Date: 2022-04-25

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