Durasphere ® EXP 890-215

GUDID 00858015005004

Injectable Bulking Agent

Carbon Medical Technologies, Inc.

Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable

• Primary Device ID: 00858015005004
• NIH Device Record Key: ece80d63-45e3-4a00-a618-97e4a651cb00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durasphere ® EXP
• Version Model Number: 890-215
• Catalog Number: 890-215
• 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

• Total Volume: 1 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858015005004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980053

FDA Product Code

• LNM: Agent, Bulking, Injectable For Gastro-Urology Use

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: 2018-07-06
• Device Publish Date: 2014-09-17

On-Brand Devices [Durasphere ® EXP ]

• 00858015005011: Injectable Bulking Agent
• 00858015005004: Injectable Bulking Agent