AccessGUDID - DEVICE: Optilume Urethral Drug Coated Balloon (00853095008310)

GUDID

Device Identifier (DI) Information

Brand Name: Optilume Urethral Drug Coated Balloon
Version or Model: 1110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1110-10050B
Company Name: Urotronic, Inc.

Primary DI Number: 00853095008310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080558603 *Terms of Use

Device Description: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use.

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:	Yes
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?
63213	Urethral dilatation catheter, drug-eluting	A sterile, flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage; it includes a drug (e.g., chemotherapy drug) intended to be eluted in situ. The device is typically designed with an inflatable dilation balloon. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QRH	Catheter, Balloon, Urethral, Drug-Coated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P210020	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: 10 Millimeter
Balloon Length: 50 Millimeter
Balloon Rated Burst Pressure: 10 Atmosphere

Device Record Status

Public Device Record Key: 3133c732-0297-45ac-a7a8-fe97b6183174
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 04, 2022