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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00821925018655PackageGS16Not in 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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10

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