FDA.reportPublic FDA data

Peng's Multifunctional Operative Dissectors (Electrosurgical Pencil)

Primary DI
16924274957635
Brand
Peng's Multifunctional Operative Dissectors (Electrosurgical Pencil)
Company
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
Model
3810T
Published
2021-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040780000ELECTROSURGICAL PENCILSHangzhou Shuyou Medical Instrument Company, Ltd.2005-02-10GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16924274957635PackageGS125In Commercial Distribution
06924274957638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692427495763516924274957635
06924274957638069242749576386924274957638

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
421340711
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06924274910008Peng’s Multifunctional Operative Dissector(PMOD)SY-IA-02017-03-10
06924274910015Peng’s Multifunctional Operative Dissector(PMOD)SY-IA-12017-03-10
06924274910022Peng’s Multifunctional Operative Dissector(PMOD)SY-IA-22017-03-10
06924274910039Peng’s Multifunctional Operative Dissector(PMOD)SY-IA(J)-02017-03-10
06924274910060Peng’s Multifunctional Operative Dissector(PMOD)SY-IB-22017-03-10
06924274910077Peng’s Multifunctional Operative Dissector(PMOD)SY-IB-32017-03-10
06924274910084Peng’s Multifunctional Operative Dissector(PMOD)SY-IIA-02017-03-10
06924274910091Peng’s Multifunctional Operative Dissector(PMOD)SY-IIA-12017-03-10
06924274910107Peng’s Multifunctional Operative Dissector(PMOD)SY-IIA-22017-03-10
06924274910121Peng’s Multifunctional Operative Dissector(PMOD)SY-IIA(N)-12017-03-10
06924274910138Peng’s Multifunctional Operative Dissector(PMOD)SY-IIA(N)-22017-03-10
06924274910145Peng’s Multifunctional Operative Dissector(PMOD)SY-IIB-02017-03-10
06924274910152Peng’s Multifunctional Operative Dissector(PMOD)SY-IIB-12017-03-10
06924274910169Peng’s Multifunctional Operative Dissector(PMOD)SY-IIB-22017-03-10
06924274910183Peng’s Multifunctional Operative Dissector(PMOD)SY-IIB(N)-12017-03-10
06924274910190Peng’s Multifunctional Operative Dissector(PMOD)SY-IIB(N)-22017-03-10
06924274910206Peng’s Multifunctional Operative Dissector(PMOD)SY-IIB(JN)-02017-03-10
06924274910213Peng’s Multifunctional Operative Dissector(PMOD)SY-IIIA-02017-03-10
06924274910220Peng’s Multifunctional Operative Dissector(PMOD)SY-IIIA-12017-03-10
06924274910237Peng’s Multifunctional Operative Dissector(PMOD)SY-IIIA-22017-03-10

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Primary DI, Brand, Company table
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