Peng’s Multifunctional Operative Dissector(PMOD)

Primary DI
6924274911005
Brand
Peng’s Multifunctional Operative Dissector(PMOD)
Company
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
Model
SY-IIA(N)-1
Published
2017-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
6924274911005PackageGS120In Commercial Distribution
06924274910121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6924274911005069242749110056924274911005
06924274910121069242749101216924274910121

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
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
false

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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