Single-use Biliary Pancreaticobiliary Scope

Primary DI
06970462546221
Brand
Single-use Biliary Pancreaticobiliary Scope
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
CL-B
Published
2025-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FBNCholedochoscope And Accessories, Flexible/Rigid
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
KOMAdhesive, Denture, Acacia And Karaya With Sodium Borate
NTNLed Light Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBNCholedochoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
KOMAdhesive, Denture, Acacia And Karaya With Sodium BorateDental1
NTNLed Light SourceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241444000Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2025-01-21FBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970462546221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970462546221069704625462216970462546221

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video choledochoscope, single-useAn 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. It is typically introduced via a flexible duodenoscope and anatomical images are transmitted to a monitor for viewing typically through a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
403655303
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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06970462547488Single-use Ureteral Access SheathY-08-502026-02-10
06970462547495Single-use Ureteral Access SheathY-08-552026-02-10
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