Bur PM2-95 80K Diam C Ø4.0 St 1100326-001

GUDID 17630055502978

Bien-Air Surgery SA

Diamond ENT bur, single-use

• Primary Device ID: 17630055502978
• NIH Device Record Key: 747ff78d-a818-4d40-98df-d382555881e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bur PM2-95 80K Diam C Ø4.0 St
• Version Model Number: 1100326
• Catalog Number: 1100326-001
• 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	17630055502978 [Primary]
GS1	27630055502975 [Package]; Package: Box [1 Units]; In Commercial Distribution
HIBCC	J00711003260011 [Previous]

FDA Product Code

• EQJ: Bur, Ear, Nose And Throat

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 PM2-95 80K Diam C Ø4.0 St]

• 17630055502978: 1100326
• 17630055514674: 1101204