FDA.reportPublic FDA data

NeoGen

Primary DI
05060440520228
Brand
NeoGen
Company
ENERGIST LIMITED
Model
NeoGen 25mm 1x Nozzle (Grey)
Catalog number
830-023
Device description
NeoGen 25mm 1x Nozzle (Grey)
Published
2019-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K132754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132754000NEOGEN PSR SYSTEMEnergist, Ltd.2013-12-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060440520225PackageGS15In Commercial Distribution
05060440520228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506044052022515060440520225
05060440520228050604405202285060440520228

GMDN Terms#

Term, Definition table
TermDefinition
Nitrogen plasma skin surface treatment systemA mobile assembly of devices intended to treat a variety of skin conditions (e.g., acne scars, actinic keratosis, wrinkles, superficial skin lesions, warts) through controlled heating of the skin surface via application of nitrogen plasma. It consists of a mains electricity (AC-powered) generator/control unit and a hand-held applicator; it may include a N2 cylinder(s) and additional hardware (e.g., foot-switch). Typically radio-frequency energy is used to convert N2 into N2 plasma which exits the handpiece as a pulsed beam. This device is intended to be used by a professional in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
735769528
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060440520198NeoGenNeoGen 5mm 1x Nozzle (Black)830-0062019-04-03
05060440520204NeoGenNeoGen 25mm 1x Nozzle (Black)830-0242019-04-03
05060440520235NeoGenNeoGen 5mm 3x Nozzle (Black)830-0572019-04-02
05060440520242NeoGenNeoGen 25mm 3x Nozzle (Black)830-0582019-04-02
05060440520105Neogen Handpiece Blk830-0092021-05-13
05060440520099NeoGenPSR830-0082019-04-01
05060440520334NeoGen SPA Grey Trolley930-0232021-08-05
05060440520129Neogen Handpiece Gry830-0312021-05-13
05060440520273Neogen Trolley Blk930-0022021-05-13
05060440520280Neogen Trolley Gry930-0202021-05-13
05060440520211NeoGenNeoGen 5mm 1x Nozzle (Grey)830-0332019-04-03
05060440520259NeoGenNeoGen 5mm 3x Nozzle (Grey)830-0592019-04-03
05060440520266NeoGenNeoGen 25mm 3x Nozzle (Grey)830-0602019-04-03
15060440520195NeoGenNeoGen 5mm 1x Nozzle (Black)830-0062019-04-03
15060440520201NeoGenNeoGen 25mm 1x Nozzle (Black)830-0242019-04-03
15060440520218NeoGenNeoGen 5mm 1x Nozzle (Grey)830-0332019-04-03
15060440520225NeoGenNeoGen 25mm 1x Nozzle (Grey)830-0232019-04-03
15060440520256NeoGenNeoGen 5mm 3x Nozzle (Grey)830-0592019-04-03
15060440520263NeoGenNeoGen 25mm 3x Nozzle (Grey)830-0602019-04-03
15060440520232NeoGenNeoGen 5mm 3x Nozzle (Black)830-0572019-04-02

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