FDA.report

BOVIE

Primary DI
10607151010840
Brand
BOVIE
Company
BOVIE MEDICAL CORPORATION
Model
BA2455NA
Catalog number
BA2455NA
Device description
DISPOSABLE BIPOLAR ABLATOR, 2.4MM, 55° , NON-ASPIRATING
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10607151010840PackageGS11In Commercial Distribution
00607151010843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715101084010607151010840
00607151010843006071510108436071510108430607151010843

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
079940465
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
false
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 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

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00190776417932MillenniumAvalign Technologies, Inc.GEI2026-03-23
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00190776418076MillenniumAvalign Technologies, Inc.GEI2026-03-23
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00653405013924CONMEDConmed CorporationGEI2026-03-23
00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
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08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108166DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
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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