Direct Inject 79-45905

GUDID 07613327123265

DirectInject On-Demand HA Cement

Stryker Leibinger GmbH & Co. KG

Bone matrix implant, synthetic

• Primary Device ID: 07613327123265
• NIH Device Record Key: ffe46352-a722-4eea-af95-52ef53ec6346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Direct Inject
• Version Model Number: 79-45905
• Catalog Number: 79-45905
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327123265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143661

FDA Product Code

• GXP: METHYL METHACRYLATE FOR CRANIOPLASTY

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: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Direct Inject]

• 07613327123371: DirectInject On-Demand HA Cement
• 07613327123272: DirectInject On-Demand HA Cement
• 07613327123265: DirectInject On-Demand HA Cement