Cable for Perforator Motor 1601111-001

GUDID 17630055507799

Bien-Air Surgery SA

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

• Primary Device ID: 17630055507799
• NIH Device Record Key: 6c162d90-d95f-4c7b-b8d7-59dc1cb8ceb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cable for Perforator Motor
• Version Model Number: 362642
• Catalog Number: 1601111-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	07630055507792 [Primary]
GS1	17630055507799 [Package]; Contains: 07630055507792; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173066

FDA Product Code

• HBC: Motor, Drill, Electric

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-02
• Device Publish Date: 2023-02-22

Devices Manufactured by Bien-Air Surgery SA

• 27630055514626 - Bur PM2-70 80K diam C Ø2.3 St: 2024-04-09
• 27630055514732 - Bur PM2-70 80K diam C Ø3.1 St: 2024-04-09
• 17630055515756 - Bur PM2-70 80K diam Ø0.6 St: 2024-04-09
• 17630055515763 - Bur PM2-70 80K diam Ø0.8 St: 2024-04-09
• 27630055515777 - Bur PM2-70 80K diam Ø1.0 St: 2024-04-09
• 27630055515784 - Bur PM2-70 80K diam Ø1.4 St: 2024-04-09
• 27630055515791 - Bur PM2-70 80K diam Ø1.8 St: 2024-04-09
• 27630055515807 - Bur PM2-70 80K diam Ø2.3 St: 2024-04-09