PM2-S150 1600978-001

GUDID J00716009780

Bien-Air Surgery SA

Drilling power tool attachment, basic

• Primary Device ID: J00716009780
• NIH Device Record Key: 52df0812-a85b-461d-84a2-0c5c227c6e0a
• Commercial Distribution Discontinuation: 2023-02-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PM2-S150
• Version Model Number: 1600978
• Catalog Number: 1600978-001
• 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: 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	J00716009780 [Direct Marking]
HIBCC	J00716009780011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173066

FDA Product Code

• HBC: Motor, Drill, Electric

Sterilization

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

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

[J00716009780]

Moist Heat or Steam Sterilization

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 [PM2-S150]

• J00716009780: 1600978
• 17630055505924: 1600978