FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925034433
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
131500
Device description
DISPOSABLE BIPOLAR NASAL CAUTERY - SINGLE USE 18 GAUGE TIP, LG OF TIP 4.0 MM OVERALL LG 175 MM
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQOUnit, cautery, thermal, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQOUnit, Cautery, Thermal, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864402000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864402000BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBENew England Surgical Instrument Corp.1987-01-20GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925018655PackageGS16In Commercial Distribution
00821925034433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925018655008219250186558219250186550821925018655
00821925034433008219250344338219250344330821925034433

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 inert gas-enhanced electrosurgery.

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10609960000852Geiger TCU Cautery SheathDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
10609960000999Thermalite Disposable TCU ElectrodesDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
10609960001002Thermalite Disposable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
10609960001019Thermalite Disposable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000787Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000794Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000800Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000817Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000824Geiger TCU HandpieceDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000831Geiger TCU HandpieceDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000848Geiger TCU 100 HandpieceDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000862Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000879Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000886Geiger Resuable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000893Geiger TCU Reusable ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000909Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000916Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000923Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000930Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000947Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000954Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000961Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000978Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960000985Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001036Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001043Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001050Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001067Geiger Reusable TCU ElectrodesDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001104Geiger Reusable TCU ElectrodeDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10
00609960001111Geiger Thermal Cautery UnitDERMATOLOGIC LAB AND SUPPLY, INC.HQO2018-07-10