Bur Cranial Spiral 10mm St 1100386-001

GUDID 27630055503514

Bien-Air Surgery SA

Cranial bur, single-use

• Primary Device ID: 27630055503514
• NIH Device Record Key: bf3f7df2-8bc3-40ad-ad94-2b2ad27cdbb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bur Cranial Spiral 10mm St
• Version Model Number: 1100386
• Catalog Number: 1100386-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	17630055503517 [Primary]
GS1	27630055503514 [Package]; Contains: 17630055503517; Package: Box [1 Units]; In Commercial Distribution
HIBCC	J00711003860011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173066

FDA Product Code

• HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)

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: 2023-02-17
• Device Publish Date: 2023-02-09

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