CRW Non-XY frame Mechanical Set KIT 700-020834-00

GUDID 27290114061104

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114061104
NIH Device Record Key9f3e8d86-ad45-485a-96cf-965fcbf78df4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRW Non-XY frame Mechanical Set KIT
Version Model Number2
Catalog Number700-020834-00
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
GS127290114061104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


[27290114061104]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-25
Device Publish Date2021-02-17

On-Brand Devices [CRW Non-XY frame Mechanical Set KIT]

272901140611042
27290114064082Long Bengun

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