FDA.reportPublic FDA data

FMwand

Primary DI
00859729006127
Brand
FMwand
Company
DOMAIN SURGICAL, INC.
Model
2121S
Catalog number
FM2121S
Device description
FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Blade
Published
2016-06-10
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140384000FMWAND HANDPIECE SEDomain Surgical, Inc.2014-05-23GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859729006124PackageGS11In Commercial Distribution
20859729006121PackageGS15In Commercial Distribution
00859729006127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085972900612410859729006124
2085972900612120859729006121
00859729006127008597290061278597290061270859729006127

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device.

Regulatory Flags#

DUNS number
963249342
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859729006059FMwand2101FM21012016-06-08
00859729006066FMwand2102FM21022016-06-09
00859729006073FMwand2121FM21212016-06-10
00859729006080FMwand2301FM23012016-06-09
00859729006097FMwand2302FM23022016-06-09
00859729006103FMwand2101SFM2101S2016-06-10
00859729006110FMwand2102SFM2102S2016-06-10
00859729006134FMwand2301SFM2301S2016-06-10
00859729006141FMwand2302SFM2302S2016-06-10
00859729006158FMsealer3001FM30012016-06-15
00859729006165FMsealer4001FM40012016-09-22
00859729006172FMwand2321SFM2321S2016-09-22
00859729006004FMXG1FMG12016-06-08
00859729006011FMXDPMFMDPM2016-06-08
00859729006028FMXRPMFMRPM2016-06-08
00859729006035FMXG1FPFMG1FP2016-06-08
20859729006053FMwand2101FM21012016-06-08
20859729006060FMwand2102FM21022016-06-09
20859729006077FMwand2121FM21212016-06-10
20859729006084FMwand2301FM23012016-06-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006129Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006136Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006143Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006150Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006167Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006174Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006181Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006198Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006204Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006211Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006228Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006235Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006242Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006266Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006273Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006310Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006341Triple Footswitch & CableELLIQUENCE, LLCGEI2026-06-02
00846338007133Trigger-Flex Quad Pro Bipolar SystemELLIQUENCE, LLCGEI2026-06-02
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-02
00846338004712Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004729Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004736Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01