FDA.reportPublic FDA data

Peng’s Multifunctional Operative Dissector(PMOD)

Primary DI
06924274910053
Brand
Peng’s Multifunctional Operative Dissector(PMOD)
Company
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
Model
SY-IB-1
Published
2017-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
06924274910053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06924274910053069242749100536924274910053

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421340711
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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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