Large Pedicle Sounder 101-0035

GUDID 00810097803503

Large Pedicle Sounder

Osteocentric Technologies, Inc.

Pedicle screw guide

• Primary Device ID: 00810097803503
• NIH Device Record Key: 9fe1d9a1-2538-4df6-b0d8-27f418ccaf4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Pedicle Sounder
• Version Model Number: 101-0035
• Catalog Number: 101-0035
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810097803503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221332

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00810097803503]

Moist Heat or Steam Sterilization

[00810097803503]

Moist Heat or Steam Sterilization

[00810097803503]

Moist Heat or Steam Sterilization

[00810097803503]

Moist Heat or Steam Sterilization

[00810097803503]

Moist Heat or Steam Sterilization

[00810097803503]

Moist Heat or Steam Sterilization

[00810097803503]

Moist Heat or Steam Sterilization

[00810097803503]

Moist Heat or Steam Sterilization

[00810097803503]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-13
• Device Publish Date: 2024-12-05

Devices Manufactured by Osteocentric Technologies, Inc.

• 00810074302364 - 120mm Locking Lateral Distal Fibula Plate Left: 2024-12-17 120mm Locking Lateral Distal Fibula Plate Left
• 00810074302371 - 140mm Locking Lateral Distal Fibula Plate Left: 2024-12-17 140mm Locking Lateral Distal Fibula Plate Left
• 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
• 00810074305013 - 4.0 x 125mm Drill Bit Cann AO: 2024-12-16 4.0 x 125mm Drill Bit Cann AO
• 00810074306119 - 2.8 x 125mm Drill Bit Cann AO: 2024-12-16 2.8 x 125mm Drill Bit Cann AO
• 00810074306133 - 1.6mm Guide Wire Smooth Trocar 150mm: 2024-12-16 1.6mm Guide Wire Smooth Trocar 150mm
• 00810074306140 - 1.6mm Guide Wire Smooth Trocar 230mm: 2024-12-16 1.6mm Guide Wire Smooth Trocar 230mm