5.2mm Fastener Tap 110470

GUDID 00816950029547

5.2mm Fastener Tap

Osteocentric Technologies, Inc.

Bone tap, reusable

• Primary Device ID: 00816950029547
• NIH Device Record Key: eadd50f6-753a-443e-94fc-9e88292589e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5.2mm Fastener Tap
• Version Model Number: 110470
• Catalog Number: 110470
• Company DUNS: 089645059
• Company Name: Osteocentric Technologies, 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: 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: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com

Device Dimensions

• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter
• Outer Diameter: 5.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950029547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210247

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

[00816950029547]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08

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• 00810074302388 - 120mm Locking Lateral Distal Fibula Plate Right: 2024-12-17 120mm Locking Lateral Distal Fibula Plate Right
• 00810074302395 - 140mm Locking Lateral Distal Fibula Plate Right: 2024-12-17 140mm Locking Lateral Distal Fibula Plate Right
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• 00810074306119 - 2.8 x 125mm Drill Bit Cann AO: 2024-12-16 2.8 x 125mm Drill Bit Cann AO
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• 00810074306140 - 1.6mm Guide Wire Smooth Trocar 230mm: 2024-12-16 1.6mm Guide Wire Smooth Trocar 230mm