Peng's Multifunctional Operative Dissector(Electrosurgical Pencil)

GUDID 16924274957857

Zhejiang Shuyou Surgical Instrument Co.,Ltd.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID16924274957857
NIH Device Record Key3fd7b619-55d2-4cf7-8753-4d9498530a43
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeng's Multifunctional Operative Dissector(Electrosurgical Pencil)
Version Model Number2A-D608-SG0013
Company DUNS421340711
Company NameZhejiang Shuyou Surgical Instrument 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106924274957850 [Primary]
GS116924274957857 [Package]
Contains: 06924274957850
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


[16924274957857]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-13
Device Publish Date2022-05-05