Cadwell

GUDID 26955739000105

Xi'an Friendship Medical Electronics Co.,Ltd.

Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium
Primary Device ID26955739000105
NIH Device Record Key40aaab4b-3541-42b4-85a1-051bd9312ba8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCadwell
Version Model Number302294-000-020
Company DUNS529249095
Company NameXi'an Friendship Medical Electronics Co.,Ltd.
Device Count4
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
GS106955739000101 [Unit of Use]
GS116955739000108 [Primary]
GS126955739000105 [Package]
Contains: 16955739000108
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29