Orbitum VI Staple FO-1001-1208

GUDID B565FO100112080

12mm Hourglass Staple

CPM MEDICAL CONSULTANTS, LLC

Orthopaedic bone staple, non-adjustable, non-sterile

• Primary Device ID: B565FO100112080
• NIH Device Record Key: ceea250d-0eff-4b87-960d-92e5a6a5bd4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbitum VI Staple
• Version Model Number: Rev A
• Catalog Number: FO-1001-1208
• Company DUNS: 017138000
• Company Name: CPM MEDICAL CONSULTANTS, LLC
• 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: true
• 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: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565FO100112080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173693

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

[B565FO100112080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-19
• Device Publish Date: 2021-02-11

On-Brand Devices [Orbitum VI Staple]

• B565FO100120120: 20mm Hourglass Staple
• B565FO100116100: 16mm Hourglass Staple
• B565FO100112080: 12mm Hourglass Staple