Reprocessed Long Narrow Blade, 29.5 x 7 mm

GUDID B390540031151

SURETEK MEDICAL

Surgical power tool system handpiece, sawing, line-powered

• Primary Device ID: B390540031151
• NIH Device Record Key: 65021be6-d995-4a9e-acce-4d534b6ba4cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Long Narrow Blade, 29.5 x 7 mm
• Version Model Number: 5400-3-115
• 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	B390540031151 [Primary]

FDA Product Code

• GFA: Blade, Saw, General & Plastic Surgery, Surgical

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: 2021-05-04
• Device Publish Date: 2021-04-26

On-Brand Devices [Reprocessed Long Narrow Blade, 29.5 x 7 mm]

• B390229631151: 2296-3-115
• B390540031151: 5400-3-115