AccessGUDID - DEVICE: Fujifilm Surgical System (00856853006030)

GUDID

Device Identifier (DI) Information

Brand Name: Fujifilm Surgical System
Version or Model: XL-4450FN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: FUJIFILM NEW DEVELOPMENT U.S.A., INC.

Primary DI Number: 00856853006030
Issuing Agency: GS1
Commercial Distribution End Date: December 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 005065629 *Terms of Use

Device Description: Light Source

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":	No
For Single-Use:	No
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?
34540	Endoscopic video image processing/light source system	A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0393a50a-f470-4603-be1e-ef3a6d99f8bc
Public Version Date: December 15, 2020
Public Version Number: 6
DI Record Publish Date: May 17, 2017