Sterile electrode's cable STR-000664-11

GUDID 17290114064276

ALPHA OMEGA ENGINEERING CO. LTD.

Electrical-only medical device connection cable, single-use
Primary Device ID17290114064276
NIH Device Record Key572cd961-fb88-4e51-9182-7d9699b58588
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile electrode's cable
Version Model NumberSterile electrode's cable
Catalog NumberSTR-000664-11
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290114064279 [Primary]
GS117290114064276 [Package]
Contains: 07290114064279
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-16
Device Publish Date2022-11-08