Durasphere ® EXP

Basic Information

• Brand Name: Durasphere ® EXP
• Primary DI: 00858015005004
• Version / Model: 890-215
• Catalog Number: 890-215
• Company Name: Carbon Medical Technologies, Inc.
• Labeler DUNS: 883094039
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ece80d63-45e3-4a00-a618-97e4a651cb00

Device Description

Injectable Bulking Agent

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60704	Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable	A sterile, implantable, non-bioabsorbable synthetic material (e.g., hydrophilic polyacrylamide gel) intended for submucosal injection in the urinary tract (urethra, urinary bladder, and/or distal ureter) to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of stress urinary incontinence (SUI) and/or vesicoureteral reflux (VUR). It is in the form of a gel material typically preloaded in a disposable syringe and is implanted using an endoscope and/or other dedicated instruments.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858015005004	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P980053	003
P980053	004
P980053	006
P980053	007
P980053	008
P980053	009
P980053	016

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Does not require refrigeration
• Type: Handling Environment Temperature
• Temperature Range: 60 – 90 Degrees Fahrenheit