Cranio Guard 15mm rotating 1600879-001

GUDID J00716008790

Bien-Air Surgery SA

Trephining power tool attachment

• Primary Device ID: J00716008790
• NIH Device Record Key: 8bc096cd-e5eb-46ba-bd3e-fd6460ca5ac0
• Commercial Distribution Discontinuation: 2023-02-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cranio Guard 15mm rotating
• Version Model Number: 1600879
• Catalog Number: 1600879-001
• 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	J00716008790 [Direct Marking]
HIBCC	J00716008790011 [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

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

Moist Heat or Steam Sterilization

[J00716008790]

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 [Cranio Guard 15mm rotating]

• J00716008790: 1600879
• 17630055505801: 1600879