Sterile LeadConfirm STR-S00041-00

GUDID 17290114063408

ALPHA OMEGA ENGINEERING CO. LTD.

Electrical-only medical device connection cable, single-use
Primary Device ID17290114063408
NIH Device Record Key7cf6769d-0ab7-4b2a-a325-b3a6efd3fbfe
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile LeadConfirm
Version Model NumberSterile LeadConfirm
Catalog NumberSTR-S00041-00
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
GS107290114063401 [Primary]
GS117290114063408 [Package]
Contains: 07290114063401
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 Date2023-05-22
Device Publish Date2023-05-12

On-Brand Devices [Sterile LeadConfirm]

17290114064474Sterile LeadConfirm
17290114064467Sterile LeadConfirm
17290114064450Sterile LeadConfirm
17290114064443Sterile LeadConfirm
17290114064436Sterile LeadConfirm
17290114064313Sterile LeadConfirm
17290114064429Sterile LeadConfirm
17290114064412Sterile LeadConfirm
07290114064392Sterile LeadConfirm
17290114064399Sterile LeadConfirm
17290114064382Sterile LeadConfirm
17290114064375Sterile LeadConfirm
17290114064368Sterile LeadConfirm
17290114064351Sterile LeadConfirm
17290114064344Sterile LeadConfirm
17290114064337Sterile LeadConfirm
17290114064320Sterile LeadConfirm
17290114064306Sterile LeadConfirm
17290114064290Sterile LeadConfirm
17290114063989Sterile LeadConfirm
17290114063828Sterile LeadConfirm
17290114063408Sterile LeadConfirm
17290114063231Sterile LeadConfirm
17290114063040Sterile LeadConfirm
17290114063033Sterile LeadConfirm
17290114063026Sterile LeadConfirm
17290114063002Sterile LeadConfirm
17290114062999Sterile LeadConfirm
17290114062333Sterile LeadConfirm
17290114064009Sterile LeadConfirm
17290114063996Sterile LeadConfirm
07290114063845Sterile LeadConfirm
17290114063835Sterile LeadConfirm
17290114063811Sterile LeadConfirm
17290114063804Sterile LeadConfirm
17290114063415Sterile LeadConfirm
17290114063262Sterile LeadConfirm
17290114061497Sterile LeadConfirm

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