FDA.reportPublic FDA data

Beamer AVEO

Primary DI
10845854081501
Brand
Beamer AVEO
Company
Conmed Corporation
Model
AVEO-ESU
Catalog number
AVEO-ESU
Device description
Beamer AVEO™ Electrosurgical Generator
Published
2022-10-12
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

Contact Domains#

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
K214058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214058000Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure ReducerConmed Corporation2022-08-26GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845854081501Direct MarkingGS10
20845854081508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084585408150110845854081501
2084585408150820845854081508

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced electrosurgical systemAn assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure62 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure60 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24
20845854036584SEQUENTMR004CMR004C2015-10-24
10653405044703CORE DYNAMICSCD1406CD14062026-03-23
10653405045083CORE DYNAMICSCD1608FHCD1608FH2026-03-24
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26