PMRM 1122 95mm 1600340-001

GUDID J00716003400

Bien-Air Surgery SA

Drilling power tool attachment, basic

• Primary Device ID: J00716003400
• NIH Device Record Key: f178bbb4-57c1-45dc-a1ae-bcd8f8ec0d75
• Commercial Distribution Status: 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: 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	J00716003400 [Direct Marking]
HIBCC	J00716003400011 [Primary]

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

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

[J00716003400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-10
• Device Publish Date: 2019-01-07

On-Brand Devices [PMRM 1122 95mm]

• J00716003400: 1600340
• 17630055505177: 1600340