AccessGUDID - DEVICE: Achilles EXPII (00840682116978)

GUDID

Device Identifier (DI) Information

Brand Name: Achilles EXPII
Version or Model: v1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GE Medical Systems (China) Co.,Ltd.

Primary DI Number: 00840682116978
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 654658731 *Terms of Use

Device Description: BONE ULTRASONOMETER, ACHILLES

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?
40779	Bone absorptiometric ultrasound system	An assembly of devices used to produce bone density measurements and other calculations based on data obtained from transmitted and reflected ultrasound (US) waves. Also called a bone densitometer, it has an integrated ultrasound transducer to deliver an ultrasound beam to an anatomical region of interest. Information obtained from detection and analysis of resulting echoes is used in calculations to estimate bone mineral density or subcutaneous fat, or to make other quantitative assessments (e.g., fracture risk). It typically incorporates an ultrasound transducer, detection electronics, a control panel, a computer, software programs, a video display, and a patient positioning system (PPS).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUA	Bone sonometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103633	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 Temperature: between 18 and 27 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3936b9bc-1347-4b36-81d3-47032261b4e7
Public Version Date: May 26, 2025
Public Version Number: 7
DI Record Publish Date: June 27, 2016