Mechanical Accessories Sterilization Net Tray 366-000322-22

GUDID 07290114061209

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID07290114061209
NIH Device Record Keyfc60fa4c-42e4-4b04-9055-e0928d0467db
Commercial Distribution StatusIn Commercial Distribution
Brand NameMechanical Accessories Sterilization Net Tray
Version Model Number1
Catalog Number366-000322-22
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290114061209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290114061209]

Moist Heat or Steam Sterilization


[07290114061209]

Moist Heat or Steam Sterilization


[07290114061209]

Moist Heat or Steam Sterilization


[07290114061209]

Moist Heat or Steam Sterilization


[07290114061209]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-08
Device Publish Date2022-05-31

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