Sterile Micro Needle Cartridge

GUDID 08800017100616

Blister Pack

shenb Co., Ltd.

Radio-frequency skin surface treatment system
Primary Device ID08800017100616
NIH Device Record Key53509deb-8666-4bee-ac47-b22aa1eeb5c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Micro Needle Cartridge
Version Model NumberSmart RF 36PIN TIP II
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800017100616 [Primary]
GS108800017100623 [Package]
Package: [5 Units]
In Commercial Distribution
GS108800017100630 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-16
Device Publish Date2021-12-08

On-Brand Devices [Sterile Micro Needle Cartridge]

08800017100784Blister Pack
08800017100753Blister Pack
08800017100678Blister Pack
08800017100647Blister Pack
08800017100616Blister Pack
08800017100579Blister Pack

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