Achilles EXPII

GUDID 00840682116978

GE Medical Systems (China) Co.,Ltd.

Bone absorptiometric ultrasound system
Primary Device ID00840682116978
NIH Device Record Key3936b9bc-1347-4b36-81d3-47032261b4e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAchilles EXPII
Version Model Numberv1
Company DUNS654658731
Company NameGE Medical Systems (China) Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682116978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUABone sonometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-12
Device Publish Date2016-06-27

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