Device
Minimum Required Working Channel :3.7mm,Minimum Working Channel Width:1.2mm
Manufacturer
Micro-Tech (Nanjing) Co., Ltd.
Micro-Tech (Nanjing) Co., Ltd.
Model: CDS22009
DI: 06932503563772
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Minimum Required Working Channel :3.7mm,Minimum Working Channel Width:1.2mm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
846568fe-2df3-48e6-9e20-2667d366826c
Distribution Status:
In Commercial Distribution
DUNS Number:
530269083
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
BOX
Item #1 - Device ID:
16932503563779
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06932503563772
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06932503563772
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
CASE
Item #3 - Device ID:
26932503563776
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
5
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
16932503563779
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 64055
Name: Flexible video choledochoscope, single-use
Definition:
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.
FDA Product Codes
KQM
Camera, Surgical And Accessories
Premarket Submissions
Submission Number:
K221784
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
1.2
Item #1 - Size Type:
Pore Size
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
3.2
Item #2 - Size Type:
Outer Diameter