PM PERFO + Cable 1700500-001

GUDID J00717005000011

Bien-Air Surgery SA

Manual cranial rotary handpiece, reusable

• Primary Device ID: J00717005000011
• NIH Device Record Key: 64f73e03-cb1d-46e5-bd3a-9d4d071402e1
• Commercial Distribution Discontinuation: 2023-02-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PM PERFO + Cable
• Version Model Number: 1700500
• Catalog Number: 1700500-001
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
HIBCC	J00717005000011 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-13
• Device Publish Date: 2019-01-07

On-Brand Devices [PM PERFO + Cable]

• J00717005000011: 1700500
• 17630055506136: 1700500