FDA.reportPublic FDA data

Prostiva Hand Piece

Primary DI
M87689290
Brand
Prostiva Hand Piece
Company
Urologix LLC
Model
8929
Device description
Prostiva RF Therapy Hand Piece
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113380000PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATORMedtronic, Inc.2012-11-15GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M87689290PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid cystoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature-30 Degrees Fahrenheit135 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888.475.0772customerservice@urologix.com

Regulatory Flags#

DUNS number
785735796
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M876PT10340TargisPT10342014-09-26
M876PT10360TargisPT10362014-09-26
M876PT10380TargisPT10382014-09-26
M876RB3131A1TargisRB3131A2014-09-26
M876RB3131A2TargisRB3131A2014-09-26

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Primary DI, Brand, Company table
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