Cranio Guard 10mm fix 1600912-001

GUDID J00716009120

Bien-Air Surgery SA

Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment

• Primary Device ID: J00716009120
• NIH Device Record Key: 219c6a29-4d59-4256-9881-980cc9a4077a
• Commercial Distribution Discontinuation: 2023-02-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cranio Guard 10mm fix
• Version Model Number: 1600912
• Catalog Number: 1600912-001
• 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	J00716009120 [Direct Marking]
HIBCC	J00716009120011 [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

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

Moist Heat or Steam Sterilization

[J00716009120]

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 10mm fix]

• J00716009120: 1600912
• 17630055505863: 1600912