FDA.reportPublic FDA data

NeoGen

Primary DI
15060440520263
Brand
NeoGen
Company
ENERGIST LIMITED
Model
NeoGen 25mm 3x Nozzle (Grey)
Catalog number
830-060
Device description
NeoGen 25mm 3x 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
OTC
false
Sterile
false
Single use
false

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
15060440520263PackageGS15In Commercial Distribution
05060440520266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506044052026315060440520263
05060440520266050604405202665060440520266

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
735769528
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
true
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
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
05060440520228NeoGenNeoGen 25mm 1x Nozzle (Grey)830-0232019-04-03
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
15060440520232NeoGenNeoGen 5mm 3x Nozzle (Black)830-0572019-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078399AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
00848657078405AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
03665415002710Bipolar electrode UNIV / THIN, extra length (round ; Fr26)LAMIDEY NOURY MEDICALGEI2026-07-10
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
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00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028750E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09