Bur PM2-70 80K Diam Ø4.0 St 1100374-001

GUDID 27630055503408

Bien-Air Surgery SA

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• Primary Device ID: 27630055503408
• NIH Device Record Key: 333a3e0d-5cc2-48a0-a84b-2cbf47981bd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bur PM2-70 80K Diam Ø4.0 St
• Version Model Number: 1100374
• Catalog Number: 1100374-001
• 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	17630055503401 [Primary]
GS1	27630055503408 [Package]; Contains: 17630055503401; Package: Box [1 Units]; In Commercial Distribution
HIBCC	J00711003740011 [Previous]

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: 2023-02-16
• Device Publish Date: 2023-02-08

On-Brand Devices [Bur PM2-70 80K Diam Ø4.0 St]

• 27630055503408: 1100374
• 27630055515845: 1101225