ProACT - Blunt Trocar

Primary DI
00180668000137
Brand
ProACT - Blunt Trocar
Company
UROMEDICA INC
Model
750042
Published
2016-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00180668000137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00180668000137001806680001371806680001370180668000137

GMDN Terms#

Term, Definition table
TermDefinition
Hydraulic male urinary incontinence treatment systemAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080378479
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00180668000144ProACT - Replacement Actuator - Tissue Expanding Device II7500432016-07-15
00180668000106ProACT - Implantation Instrument Set7500412016-07-15
00180668000205ProACT - Tissue Expanding Device II7500442016-07-15
00180668000236ProACT Adjustable Continence Therapy for Men – 12 cm Implants - Patient Pack800018-122016-07-15
00180668000380ProACT Adjustable Continence Therapy for Men – 14 cm Implants - Patient Pack800018-142016-07-15
00180668000397ProACT Adjustable Continence Therapy for Men – 12 cm Single Implant - Revision800022-122016-07-15
00180668000403ProACT Adjustable Continence Therapy for Men – 14 cm Single Implant - Revision800022-142016-07-15