OptimalMTP™ 6100.0031

GUDID 00810136433494

3.1mm Drill, AO Quick Connect, Cannulated

Forma Medical, Inc.

Cannulated surgical drill bit, reusable

• Primary Device ID: 00810136433494
• NIH Device Record Key: 9cdc7168-9537-431b-b245-e509920d4217
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptimalMTP™
• Version Model Number: 6100.0031
• Catalog Number: 6100.0031
• 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

Device Dimensions

• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter
• Outer Diameter: 1.9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810136433494 [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

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

[00810136433494]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-08
• Device Publish Date: 2025-06-30

On-Brand Devices [OptimalMTP™]

• 00810136432954: 1.6mm Olive K-wire, 4 in. Long
• 00810136432947: 1.4mm Olive K-wire, 4 in. Long
• 00810136433425: RADIOLUCENT POSITIONING WEDGE, RIGHT, 10 DEGREES
• 00810136433418: RADIOLUCENT POSITIONING WEDGE, RIGHT, 5 DEGREES
• 00810136433401: RADIOLUCENT POSITIONING WEDGE, LEFT, 10 DEGREES
• 00810136433395: RADIOLUCENT POSITIONING WEDGE, LEFT, 5 DEGREES
• 00810136433388: Radiolucent Foot Plate
• 00810136433494: 3.1mm Drill, AO Quick Connect, Cannulated