DEVICE: IMAGE 1 S (04048551349779)

Download: XML | JSON

Device Identifier (DI) Information

IMAGE 1 S
11292VSU

Karl Storz GmbH & Co. KG
04048551349779
GS1
1
Video Choledochoscope IMAGE1 S
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Flexible video choledochoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). It is inserted into the body through an artificial orifice created by an incision in the abdomen (laparoscopic technique) or introduced via a flexible duodenoscope during the procedure called choledochoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. This device is commonly used to examine structures of the CBD and for the removal of stones. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FBN Choledochoscope and accessories, flexible/rigid
CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
Peracetic Acid
Ethylene Oxide
Liquid Chemical
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 23, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE