Friendship Medical

GUDID 16955739010503

Xi'an Friendship Medical Electronics Co.,Ltd.

Subdermal needle electrode
Primary Device ID16955739010503
NIH Device Record Key12e1720b-1942-4d4a-9fc4-2f8eefead19a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFriendship Medical
Version Model NumberNE-SS-100/13/0.4
Company DUNS529249095
Company NameXi'an Friendship Medical Electronics Co.,Ltd.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106955739010506 [Unit of Use]
GS116955739010503 [Primary]
GS126955739010500 [Package]
Package: Box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZElectrode, Needle

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[16955739010503]

Ethylene Oxide


[16955739010503]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-05