FDA.reportPublic FDA data

Peng's Multifunctional Operative Dissector(Electrosurgical Pencil)

Primary DI
16924274957857
Brand
Peng's Multifunctional Operative Dissector(Electrosurgical Pencil)
Company
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
Model
2A-D608-SG0013
Published
2022-05-05
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
16924274957857PackageGS110In Commercial Distribution
06924274957850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692427495785716924274957857
06924274957850069242749578506924274957850

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13