FDA.report

Bipolar Cord

Primary DI
00841494106911
Brand
Bipolar Cord
Company
Ellman International
Model
JX
Catalog number
JX
Device description
BIPOLAR CORD - AUTOCLAVABLE
Published
2017-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841494106911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494106911008414941069118414941069110841494106911

GMDN Terms

TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.

Sterilization Methods

Method

Regulatory Flags

DUNS number
079095245
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00841494102371CORNEAL SHIELDH77AH77A2016-09-21
00841494102388CORNEAL SHIELDH76AH76A2016-09-21
00841494102395CORNEAL SHIELDH75AH75A2016-09-21
00841494102401CORNEAL SHIELDSH781H7812016-09-21
00841494104801SUCTION HANDLEH78BH78B2016-09-21
00841494104818SUCTION HANDLE FOR CORNEAL SHIELDSH78AH78A2016-09-21
008414941010151/8" PIN ELECTRODE133D133D2016-09-19
00841494101305Needle ElectrodeA3D/OSA3D/OS2016-09-21
00841494101541Empire Microincision Needle ElectrodesQTEE302QTEE3022016-09-21
10841494101807RF ANGLED SUCTION COAGULATORHD42HD422016-09-21
00841494102012BALL ELECTRODED8DD8D2016-09-21
00841494102050DR. Beigi's ElectrodesTEE603TEE6032016-09-21
00841494102289BROAD NEEDLE ELECTRODEF1DF1D2016-09-21
00841494102524Dermatology ElectrodesDDERM40DDERM402016-09-21
00841494102531DIAMOND LOOP ELECTRODEC3DC3D2016-09-21
00841494102777EMPIRE microIncision Needle ElectrodesTEE316TEE3162016-09-21
00841494102784EMPIRE microIncision Needle ElectrodesTEE302TEE3022016-09-21
00841494102791EMPIRE microIncision Needle ElectrodesTEE314TEE3142016-09-21
00841494102807EMPIRE microIncision Needle ElectrodesTEE317TEE3172016-09-21
00841494102814EMPIRE microIncision Needle ElectrodesTEE326TEE3262016-09-21

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