AccessGUDID - DEVICE: NA (04260491560025)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: XCT 3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XCT 3000
Company Name: Stratec Medizintechnik GmbH

Primary DI Number: 04260491560025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 321874737 *Terms of Use

Device Description: Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography.

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?
37619	Limited-view-field CT system	An assembly of diagnostic x-ray computed tomography (CT) devices having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGI	Densitometer, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K983273	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
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 41 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 68 and 82.5 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 524f2a62-6468-4d1a-9f0e-85125ae1d08e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 26, 2017