FDA.reportPublic FDA data

Bovie

Primary DI
10607151005310
Brand
Bovie
Company
BOVIE MEDICAL CORPORATION
Model
A827V
Catalog number
A827V
Device description
REUSABLE BIPOLAR FORCEPS CORD
Published
2019-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151005310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060715100531010607151005310

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079940465
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607151006737BovieA827BPA827BP2017-02-14
10607151011526BovieAD-330-A8AD-330-A82017-03-30
10607151011601BovieAD-770-A8AD-770-A82017-03-30
10607151011649BovieAD-770R-A8AD-770R-A82017-03-30
10607151011694BovieA5A52017-03-30
10607151012028BovieAD-330-A5AD-330-A52017-03-30
10607151012042BovieAD-330R-A5AD-330R-A52017-03-30
10607151012073BovieAD-770-A5AD-770-A52017-03-30
10607151012097BovieAD-770R-A5AD-770R-A52017-03-30
10607151001114BovieIDS-200IDS-2002016-10-13
10607151001121BovieIDS-300IDS-3002016-10-13
10607151002784BovieA2250-LOANERA2250-LOANER2016-10-13
10607151002791BovieIDS-300-LOANERIDS-300-LOANER2016-10-13
10607151002807BovieIDS-200-LOANERIDS-200-LOANER2016-10-13
10607151003101BovieA3250-LOANERA3250-LOANER2016-10-13
10607151004726BovieIDS-400IDS-4002016-10-13
10607151005327BovieGS100GS1002016-10-13
10607151005334BovieA940A9402016-10-13
10607151005365BovieA940-LOANERA940-LOANER2016-10-13
10607151005525BovieA2250-DEMOA2250-DEMO2016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850067560316LaproSacSurgical Principals, IncGEI2026-05-22
ESUM3644100SutterSutter Medizintechnik GmbHGEI2026-05-22
00845854035590CONCEPTConmed CorporationGEI2026-03-24
00190776417932MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776417956MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418076MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418281MillenniumAvalign Technologies, Inc.GEI2026-03-23
00653405013924CONMEDConmed CorporationGEI2026-03-23
00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
00198506089749ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108166DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108180DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108197DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108203DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108289DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108272DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108296DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108302DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108319DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108326DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108395POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108401POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108425POTENZAJeisys Medical Inc.GEI2026-03-16
00198506089565ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-13
10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
10884450587802STAR™Merit Medical Systems, Inc.GEI2026-03-11
08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09