Leibinger RM frame Mechanical Set KIT 700-020874-00

GUDID 27290114064112

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114064112
NIH Device Record Key12f309cd-0215-4fe3-ae46-f9913499ec5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeibinger RM frame Mechanical Set KIT
Version Model NumberLong Bengun
Catalog Number700-020874-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exempttrue
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
GS127290114064112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


[27290114064112]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-22
Device Publish Date2023-09-14

On-Brand Devices [Leibinger RM frame Mechanical Set KIT]

272901140611352
27290114064112Long Bengun

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