Primary Device ID | 00840682116978 |
NIH Device Record Key | 3936b9bc-1347-4b36-81d3-47032261b4e7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Achilles EXPII |
Version Model Number | v1 |
Company DUNS | 654658731 |
Company Name | GE Medical Systems (China) Co.,Ltd. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840682116978 [Primary] |
MUA | Bone sonometer |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-02-12 |
Device Publish Date | 2016-06-27 |
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