DEVICE: FUJIFILM (04547410331493)

Download: XML | JSON

Device Identifier (DI) Information

FUJIFILM
TS-12140

FUJIFILM CORPORATION
04547410331493
GS1
1
These sterile Over-tubes are intended to be used as accessories with the FUJINON/ FUJIFILM Double Balloon Endoscopes cleared for use with Over-tubes. The Over-tubes are used to assist with the movement of the scopes inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
No
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
Endoscopic overtube, single-use A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FED endoscopic access overtube, gastroenterology-urology
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: There must be no condensation.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
October 18, 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
24547410331497 1 04547410331493 In Commercial Distribution Box
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+018002728465
xxx@xxx.xxx
CLOSE