FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925008304
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
568618
Device description
Bipolar Cable, 12'
Published
2016-10-03
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
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K831236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831236000BIPOLAR CARDNew England Surgical Instrument Corp.1983-06-02GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925008304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008304008219250083048219250083040821925008304

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
00821925043060ViziShot 2 FLEXNA-U403SX-40192020-09-23
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04953170467882THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
00841019124178KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-28
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00841019124239KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00190776439774MilleniumAvalign Technologies, Inc.GEI2026-10-26
10884521783829LigaSureCovidien LPGEI2026-10-23
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
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B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
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00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
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