PMRM 1122 95mm 1600340-001

GUDID 17630055505177

Bien-Air Surgery SA

Drilling power tool attachment, basic

• Primary Device ID: 17630055505177
• NIH Device Record Key: c46dd927-0f02-4815-9435-90956b6e05d2
• Commercial Distribution Discontinuation: 2023-02-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PMRM 1122 95mm
• Version Model Number: 1600340
• Catalog Number: 1600340-001
• 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: true
• 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
GS1	07630055505170 [Primary]
GS1	17630055505177 [Package]; Contains: 07630055505170; Package: [1 Units]; Discontinued: 2023-02-09; Not in Commercial Distribution
HIBCC	J00716003400011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792159

FDA Product Code

• ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

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

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

[17630055505177]

Moist Heat or Steam Sterilization

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

On-Brand Devices [PMRM 1122 95mm]

• J00716003400: 1600340
• 17630055505177: 1600340