2102-0131

GUDID 30808232000215

Bone Graft Substitute, 1-4mm Morsels Cancellous Chips, Beta-Tricalcium Phosphate

Stryker Corporation

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• Primary Device ID: 30808232000215
• NIH Device Record Key: 4e13a9c4-9c60-403f-b6a1-accbdc69d649
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2102-0131
• Catalog Number: 2102-0131
• Company DUNS: 149183167
• Company Name: Stryker Corporation
• 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: true
• 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(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.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 Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze

Device Identifiers

Device Issuing Agency	Device ID
GS1	00808232000214 [Primary]
GS1	30808232000215 [Package]; Contains: 00808232000214; Package: pack [10 Units]; In Commercial Distribution

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-10
• Device Publish Date: 2015-09-24

Devices Manufactured by Stryker Corporation

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• 07613327627701 - KNOTILUS+: 2024-03-15 2.4X8.9MM KNOTILUS+ HIP ANCHOR - PEEK
• 07613327623796 - KNOTILUS+: 2024-03-13 2.4X8.9MM DRILL, HIP
• 07613327623833 - KNOTILUS+: 2024-03-13 2.4X8.9MM DRILL, HARD BONE, HIP
• 07613327634686 - Iconix: 2024-03-12 Iconix DC Guide for 1.4mm anchor
• 07613327634693 - Iconix: 2024-03-12
• 07613327616675 - SPY: 2024-03-06
• 07613327616682 - SPY: 2024-03-06