Integra® PyroSphere® BRH-445-40

GUDID M269BRH445401

Spherical Burr used to create an opening in the bone.

Ascension Orthopedics, Inc.

Orthopaedic bur, reusable

• Primary Device ID: M269BRH445401
• NIH Device Record Key: f5c402ae-4d36-4972-a0e0-1274ac469061
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® PyroSphere®
• Version Model Number: BRH44540
• Catalog Number: BRH-445-40
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780242505 [Primary]
HIBCC	M269BRH445401 [Secondary]

FDA Product Code

• HTT: BURR, ORTHOPEDIC

Sterilization

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

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

[M269BRH445401]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-01-01
• Device Publish Date: 2017-09-05

On-Brand Devices [Integra® PyroSphere®]

• M269EXT430011: The PCS Implant Extractor is used to remove implants.
• M269BRH445501: Spherical Burr used to create an opening in the bone.
• M269BRH445401: Spherical Burr used to create an opening in the bone.
• M269BRH445301: Spherical Burr used to create an opening in the bone.
• M269BRH445201: Spherical Burr used to create an opening in the bone.
• M269BRH445101: Spherical Burr used to create an opening in the bone.
• M269TRL435501: Trial used to evaluate the size and fit of the implant.
• M269TRL435401: Trial used to evaluate the size and fit of the implant.
• M269TRL435301: Trial used to evaluate the size and fit of the implant.
• M269TRL435201: Trial used to evaluate the size and fit of the implant.
• M269TRL435101: Trial used to evaluate the size and fit of the implant.
• M248PYRSPHSZINSP1: PyroSphere® Sizer