AccessGUDID - DEVICE: ProACT Adjustable Continence Therapy for Men – 14 cm Implants

GUDID

Device Identifier (DI) Information

Brand Name: ProACT Adjustable Continence Therapy for Men – 14 cm Implants - Patient Pack
Version or Model: 800018-14
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: UROMEDICA INC

Primary DI Number: 00180668000380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080378479 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
31994	Hydraulic male urinary incontinence treatment system	An assembly of implantable devices intended to treat male urinary incontinence by applying pressure to partially/fully occlude the bladder neck and/or urethra, typically after radical prostatectomy or transurethral resection of the prostate. It typically consists of an inflatable pad-like device(s) (e.g., cushion, balloon) implanted around the bladder neck/urethra, port and tubing for the introduction/removal of fluid (e.g. saline) to/from the pad(s) intra- and/or postoperatively, and devices for the stabilization of the pad(s) in situ (e.g., sutures, mesh); devices for the introduction/removal of fluid via the port (e.g., needles) may also be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 85de4c73-9d4a-419c-9b0b-9dd67e62d812
Public Version Date: January 23, 2019
Public Version Number: 3
DI Record Publish Date: July 15, 2016