AccessGUDID - DEVICE: eyeMAX(TM) Single-use Video Pancreaticobiliary Scope (06932503563765)

GUDID

Device Identifier (DI) Information

Brand Name: eyeMAX(TM) Single-use Video Pancreaticobiliary Scope
Version or Model: CDS22008
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503563765
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Minimum Required Working Channel :3.7mm,Minimum Working Channel Width:1.2mm

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?
64055	Flexible video choledochoscope, single-use	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. Also known as a cholangioscope, it is inserted into the body through an artificial orifice or introduced via a flexible duodenoscope during choledochoscopy. Anatomical images are transmitted to a monitor for viewing typically through a complementary metal oxide semiconductor (CMOS) chip at the distal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQM	Camera, Surgical And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221784	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
Pore Size: 1.2 Millimeter
Outer Diameter: 3.2 Millimeter

Device Record Status

Public Device Record Key: 31080f42-96ab-4734-9611-3ac504c3bcea
Public Version Date: March 18, 2025
Public Version Number: 4
DI Record Publish Date: February 09, 2024