AccessGUDID - DEVICE: Macroplastique Implants (08717591240266)

GUDID

Device Identifier (DI) Information

Brand Name: Macroplastique Implants
Version or Model: MPQ-2.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPQ-2.5
Company Name: Uroplasty, Inc.

Primary DI Number: 08717591240266
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 804002665 *Terms of Use

Device Description: Soft tissue bulking agent indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency.

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 [?]
P040050	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 66972483-3f68-455b-89d7-703ae0c52d03
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: June 20, 2014