9mm Washer 0.9mm Height 300-0901

GUDID 00810074300353

9mm Washer 0.9mm Height

Osteocentric Technologies, Inc.

Implantable bone washer

• Primary Device ID: 00810074300353
• NIH Device Record Key: 44f1ec4b-1860-4a60-85b8-1db288c6e47d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 9mm Washer 0.9mm Height
• Version Model Number: 300-0901
• Catalog Number: 300-0901
• 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: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810074300353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150981

FDA Product Code

• HTN: Washer, Bolt Nut

Sterilization

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

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-26
• Device Publish Date: 2025-05-16

Devices Manufactured by Osteocentric Technologies, Inc.

• 00810074300353 - 9mm Washer 0.9mm Height: 2025-05-269mm Washer 0.9mm Height
• 00810074300353 - 9mm Washer 0.9mm Height: 2025-05-26 9mm Washer 0.9mm Height
• 00810074306461 - 8.0mm Drill Bit Cann Hudson Mod 270mm: 2025-05-23 8.0mm Drill Bit Cann Hudson Mod 270mm
• 00810074306997 - 2.7mm Cortical Screw Tap 145mm: 2025-05-23 2.7mm Cortical Screw Tap 145mm
• 00810074307000 - 2.0mm Drill Calibrated 145mm: 2025-05-23 2.0mm Drill Calibrated 145mm
• 00816950029530 - Large Depth Gauge 125mm: 2025-05-23 Large Depth Gauge 125mm
• 00810074309219 - POST-LAT DISTAL FIBULA PLATE 2H L: 2025-05-19 POST-LAT DISTAL FIBULA PLATE 2H L
• 00810074309226 - POST-LAT DISTAL FIBULA PLATE 2H R: 2025-05-19 POST-LAT DISTAL FIBULA PLATE 2H R
• 00810074309233 - POST-LAT DISTAL FIBULA PLATE 4H L: 2025-05-19 POST-LAT DISTAL FIBULA PLATE 4H L