AccessGUDID - DEVICE: Durasphere ® EXP (00858015005004)

GUDID

Device Identifier (DI) Information

Brand Name: Durasphere ® EXP
Version or Model: 890-215
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 890-215
Company Name: Carbon Medical Technologies, Inc.

Primary DI Number: 00858015005004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 883094039 *Terms of Use

Device Description: Injectable Bulking Agent

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LNM	Agent, Bulking, Injectable For Gastro-Urology Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980053	003
P980053	004
P980053	006
P980053	007
P980053	008
P980053	009
P980053	016

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Does not require refrigeration
Handling Environment Temperature: between 60 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: ece80d63-45e3-4a00-a618-97e4a651cb00
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 17, 2014