PlaDuo System

GUDID 08800017100159

shenb Co., Ltd.

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Primary Device ID08800017100159
NIH Device Record Key1857ba5d-3cee-468c-a167-54c5836d56bc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlaDuo System
Version Model NumberPlaDuo
Company DUNS690425442
Company Nameshenb Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS108800017100159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-05
Device Publish Date2020-12-28

On-Brand Devices [PlaDuo System]

08800017100159PlaDuo
08800017101118PlaDuo

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