Optilume BPH Pre-dilation Catheter 1137-30030

GUDID 00853095008426

The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.

Urotronic, Inc.

Urethral dilatation catheter, non-medicated
Primary Device ID00853095008426
NIH Device Record Keyaad34aab-3c47-48ac-891b-ecefdbdca5e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptilume BPH Pre-dilation Catheter
Version Model Number1137
Catalog Number1137-30030
Company DUNS080558603
Company NameUrotronic, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com
Phone763.285.7496
Emailoptilume@urotronic.com

Device Dimensions

Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere
Balloon Diameter30 Millimeter
Catheter Length30 Millimeter
Balloon Rated Burst Pressure4 Atmosphere

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853095008426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QXBDrug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-14
Device Publish Date2023-08-05

On-Brand Devices [Optilume BPH Pre-dilation Catheter]

00853095008426The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therap
00853095008150The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therap
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