Durasphere ® 890-209

GUDID 00858015005622

Injection Needle, Pencil Point

Carbon Medical Technologies, Inc.

Submucosal injection needle

• Primary Device ID: 00858015005622
• NIH Device Record Key: 83bc00b2-ec90-4910-9506-cf72c20c5466
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durasphere ®
• Version Model Number: 890-209
• Catalog Number: 890-209
• Company DUNS: 883094039
• Company Name: Carbon Medical Technologies, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 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: 8882070262
• Email: info@carbonmed.com

Device Dimensions

• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge

Operating and Storage Conditions

• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858015005622 [Primary]

FDA Product Code

• FBK: Endoscopic Injection Needle, Gastroenterology-Urology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-19
• Device Publish Date: 2016-10-12

On-Brand Devices [Durasphere ® ]

• 00858015005639: Injection Needle, Pencil Point
• 00858015005622: Injection Needle, Pencil Point
• 00858015005615: Injection Needle, Spinal Tip
• 00858015005608: Injection Needle, Spinal Tip