Reprocessed 4.2mm Full Radius Resector

GUDID B3909247A1

SURETEK MEDICAL

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• Primary Device ID: B3909247A1
• NIH Device Record Key: 5e9d0596-a66a-4bac-9da4-403290dc4ae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 4.2mm Full Radius Resector
• Version Model Number: 9247A
• 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	B3909247A1 [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: 2019-01-14
• Device Publish Date: 2018-12-13

On-Brand Devices [Reprocessed 4.2mm Full Radius Resector]

• B3909247A1: 9247A
• B390S9247A1: 4.3mm Yellow Carbon Coated, Full Radius Resector