AccessGUDID - DEVICE: Probe sensor assembly for BK 8818 and 8808e (square) (07290016936032)

GUDID

Device Identifier (DI) Information

Brand Name: Probe sensor assembly for BK 8818 and 8808e (square)
Version or Model: FPRSA00007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FPRSA00007
Company Name: UC-CARE LTD

Primary DI Number: 07290016936032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649551124 *Terms of Use

Device Description: No description.

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):	No
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?
60656	Rectal ultrasound navigational image processor	A mobile, mains electricity (AC-powered) device intended to be used in conjunction with an ultrasound imaging system and rectal ultrasound transducer to display two- and three-dimensional (3-D) ultrasound images of tissues (e.g., the prostate). It consists of a personal computer (PC) based workstation which processes data from the ultrasound imaging system, and a mechanical assembly intended to mount and track the rectal ultrasound transducer to generate a real-time 3-D image. Depending on specific software, packages may also allow for biopsy navigation and further image processing/data management.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100784	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1f90aee-9e1b-4bfb-9540-60d3e4154a1f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 15, 2017