N-Force Blue ™ IN050-8

GUDID 00889024563285

Etex Corporation

Bone graft delivery kit

• Primary Device ID: 00889024563285
• NIH Device Record Key: 8fc235d0-307c-413b-b08d-f932cff1d56e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N-Force Blue ™
• Version Model Number: IN050-8
• Catalog Number: IN050-8
• Company DUNS: 622221141
• Company Name: Etex 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18003489500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024563285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141245

FDA Product Code

• FMF: Syringe, Piston

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: 2019-12-24
• Device Publish Date: 2019-12-16

On-Brand Devices [N-Force Blue ™]

• 00889024563285: IN050-8
• 00889024563278: IN050-7