AccessGUDID - DEVICE: Luminscan(TM) Disposable Imaging Kit (06932503570060)

GUDID

Device Identifier (DI) Information

Brand Name: Luminscan(TM) Disposable Imaging Kit
Version or Model: BOP-18-55-25-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503570060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: The diameter of the balloon is 18mm, the effective length is 55mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

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":	Yes
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?
47490	Coronary optical coherence tomography system	An assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQQ	System, Imaging, Optical Coherence Tomography (Oct)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162466	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Balloon Diameter: 18 Millimeter
Balloon Length: 55 Millimeter
Length: 250 Centimeter

Device Record Status

Public Device Record Key: fc45c2e9-5ad2-489c-8467-cd66156b725e
Public Version Date: October 14, 2024
Public Version Number: 3
DI Record Publish Date: August 11, 2023