Peng's Multifunctional Operative Dissectors (Electrosurgical Pencil)

GUDID 16924274957635

Zhejiang Shuyou Surgical Instrument Co.,Ltd.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID16924274957635
NIH Device Record Keyb8275a79-740c-406b-a74b-a8c6fdf82753
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeng's Multifunctional Operative Dissectors (Electrosurgical Pencil)
Version Model Number3810T
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
GS106924274957638 [Primary]
GS116924274957635 [Package]
Contains: 06924274957638
Package: [25 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

[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


[16924274957635]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-27
Device Publish Date2021-10-19