AccessGUDID - DEVICE: Faxitron (00857069006005)

GUDID

Device Identifier (DI) Information

Brand Name: Faxitron
Version or Model: CoreVision 5x10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FAXITRON BIOPTICS, LLC

Primary DI Number: 00857069006005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968877360 *Terms of Use

Device Description: Stationary digital specimen x-ray system with 5x10 cm imager intended for the examination of Core Biopsy excisions.

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?
42282	Stationary specimen x-ray system, digital	A stationary specimen x-ray system designed for permanent fixture in one location to generate and control x-ray beams and to record the absorption patterns of x-rays passing through tissue samples (e.g., stereotactic biopsy cores taken during mammographic procedures) or amputated body parts. The data is either from analogue imaging and digitized afterwards or by digital imaging.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MWP	Cabinet,X-Ray System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082432	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: 10cd2280-7955-4390-beda-b4f557cae82e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 17, 2016