N-Force Mixing and Delivery System

GUDID 00889024430082

Zimmer, Inc.

Bone graft delivery kit

• Primary Device ID: 00889024430082
• NIH Device Record Key: e3111b71-46da-4762-a640-ee71e57a81f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N-Force Mixing and Delivery System
• Version Model Number: IN050-2
• Company DUNS: 056038268
• Company Name: Zimmer, 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024430082 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-29

Devices Manufactured by Zimmer, Inc.

• 00887868139741 - Affixus®: 2025-04-07
• 00887868139758 - Affixus®: 2025-04-07
• 00887868139765 - Affixus®: 2025-04-07
• 00887868139772 - Affixus®: 2025-04-07
• 00887868139789 - Affixus®: 2025-04-07
• 00887868139796 - Affixus®: 2025-04-07
• 00887868139802 - Affixus®: 2025-04-07
• 00887868139819 - Affixus®: 2025-04-07