AccessGUDID - DEVICE: Optilume BPH Pre-dilation Catheter (00853095008426)

GUDID

Device Identifier (DI) Information

Brand Name: Optilume BPH Pre-dilation Catheter
Version or Model: 1137
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1137-30030
Company Name: Urotronic, Inc.

Primary DI Number: 00853095008426
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080558603 *Terms of Use

Device Description: 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.

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":	No
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?
32022	Urethral dilatation catheter, non-medicated	A sterile, flexible or semi-flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage. The device is typically made of plastic and silicone materials and is available in a variety of designs whereby: 1) it may have a larger diameter than that of a normal urethra; 2) it may have an attached inflatable balloon; or 3) the leading end of the device may be moulded into an extremely slender or thread-shaped form in order to facilitate passage of a larger, following portion; it does not elute a drug. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QXB	Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220029	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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Balloon Diameter: 30 Millimeter
Catheter Length: 30 Millimeter
Balloon Rated Burst Pressure: 4 Atmosphere

Device Record Status

Public Device Record Key: aad34aab-3c47-48ac-891b-ecefdbdca5e0
Public Version Date: August 14, 2023
Public Version Number: 1
DI Record Publish Date: August 05, 2023