Saf-T-Vac Smoke and Fluid Evacuator ST9000S

GUDID 00851988007983

SURGICAL TECHNOLOGY LABORATORIES INC

Surgical plume evacuation system tube

• Primary Device ID: 00851988007983
• NIH Device Record Key: 7a82ab83-c0cd-4ad2-ba32-9c2623074775
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saf-T-Vac Smoke and Fluid Evacuator
• Version Model Number: ST9000S
• Catalog Number: ST9000S
• Company DUNS: 080380106
• Company Name: SURGICAL TECHNOLOGY LABORATORIES INC
• 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: true
• Manufacturing Date: true
• 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
GS1	00851988007983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170582

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-06

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