FDA.reportPublic FDA data

PlasmaKinetic

Primary DI
00821925039575
Brand
PlasmaKinetic
Company
Gyrus ACMI, LLC
Model
714520
Device description
PLASAMAKINETIC SYSTEM PK Plasma-Sect Instrument - Angled Loop Resecting (5/PK)
Published
2016-10-06
Public version status
Update
Distribution status
Not 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
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001270000GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODEGyrus Medical , Ltd.2000-04-28FJL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925009233PackageGS15Not in Commercial Distribution
00821925039575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925009233008219250092338219250092330821925009233
00821925039575008219250395758219250395750821925039575

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
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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00810116023813Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810116023851Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810116023875Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810116023899Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
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