Burr 6100.0004

GUDID 00810136430042

Burr, Shannon Larga 2.2mm

Forma Medical, Inc.

Orthopaedic bur, single-use

• Primary Device ID: 00810136430042
• NIH Device Record Key: 0b7855d0-1ac7-4d07-9e4d-9d80a3e102f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burr
• Version Model Number: 6100.0004
• Catalog Number: 6100.0004
• Company DUNS: 126585966
• Company Name: Forma Medical, Inc.
• 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: true
• 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: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com
• Phone: 0000000000
• Email: support@formamedical.com

Device Dimensions

• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810136430042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230945

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

[00810136430042]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-01
• Device Publish Date: 2023-12-22

On-Brand Devices [Burr]

• 00810136430004: MIS Burr, Shannon Recta 2.0mm
• 00810136430035: Burr, Shannon Recta Larga 2.2mm
• 00810136430042: Burr, Shannon Larga 2.2mm
• 00810136433159: MIS Doty Burr, 4x13mm, Reverse Wedge