PlaDuo System

GUDID 08800017101118

shenb Co., Ltd.

Nitrogen plasma skin surface treatment system
Primary Device ID08800017101118
NIH Device Record Key1ea5a976-615c-4b57-9a72-81de3e52ba52
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
GS108800017101118 [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 Date2023-11-09
Device Publish Date2023-11-01

On-Brand Devices [PlaDuo System]

08800017100159PlaDuo
08800017101118PlaDuo

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