DirectInject 79-45143

GUDID 07613327425468

STANDARDCANNULA

Stryker Leibinger GmbH & Co. KG

Bone matrix implant, synthetic

• Primary Device ID: 07613327425468
• NIH Device Record Key: cd8a567b-5527-4d64-8527-694cd9760eb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DirectInject
• Version Model Number: 79-45143
• Catalog Number: 79-45143
• 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

• Length: 5 Centimeter
• 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	07613327425468 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-11
• Device Publish Date: 2018-12-11

On-Brand Devices [DirectInject]

• 07613327425475: EXTENDED CANNULA
• 07613327425468: STANDARDCANNULA