Cadwell

GUDID 16955739013108

Xi'an Friendship Medical Electronics Co.,Ltd.

Subdermal needle electrode
Primary Device ID16955739013108
NIH Device Record Keybd5a3e20-5c46-48f8-a5f9-5e1cb4259ef8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCadwell
Version Model Number302820-000-100
Company DUNS529249095
Company NameXi'an Friendship Medical Electronics 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116955739013108 [Primary]
GS126955739013105 [Package]
Package: box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZElectrode, Needle

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[16955739013108]

Ethylene Oxide


[16955739013108]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-14