KeyFix Direct Access Needle

GUDID 08058964724021

G21 SRL

Vertebral body cement cannula

• Primary Device ID: 08058964724021
• NIH Device Record Key: 3958e64e-07af-41e0-9ebf-fe38d388b97f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KeyFix Direct Access Needle
• Version Model Number: 900094
• Company DUNS: 431529195
• Company Name: G21 SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058964724021 [Primary]

FDA Product Code

• OCJ: Spinal Channeling Instrument, Vertebroplasty

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: 2024-10-18
• Device Publish Date: 2024-10-10

On-Brand Devices [KeyFix Direct Access Needle]

• 08058964724113: 900103
• 08058964724021: 900094