FDA.reportPublic FDA data

FREDDO

Primary DI
00850064466027
Brand
FREDDO
Company
FABINJECT LLC
Model
056/24-3210
Device description
Skin cooling device
Published
2024-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242132000FREDDOFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda2024-10-18GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064466027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064466027008500644660278500644660270850064466027

GMDN Terms#

Term, Definition table
TermDefinition
Localized cutaneous/musculoskeletal cryotherapy unitAn electrically-powered unit intended to create a stream of cold air/vapour (e.g., liquid nitrogen) for application to the skin surface for various localized therapeutic applications such as relief of underlying musculoskeletal symptoms (e.g., pain, spasm, inflammation, bruising), reduction of dermal pain/inflammation, and/or reduction of thermal skin damage during dermatological laser treatments. In addition to the main unit it may include a hose and spray-producing nozzle.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13219724528fabinjectllc_regulatory@outlook.com
13219724528agg@fabinject.com.br

Regulatory Flags#

DUNS number
032329574
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850064466379Skin Cooler Roller - SMALL (lilac)SCRSMALLLILACBX012025-03-04
00850064466386Skin Cooler Roller - SMALL (blue)SCRSMALLBLUEBX012025-03-04
00850064466393Skin Cooler Roller - SMALL (green)SCRSMALLGREENBX012025-03-04
00850064466409Skin Cooler Roller - LARGE (white)SCRLARGEWHITEBX012025-03-04
00850064466416Skin Cooler Roller - LARGE (lilac)SCRLARGELILACBX012025-03-04
00850064466423Skin Cooler Roller - LARGE (blue)SCRLARGEBLUEBX012025-03-04
00850064466430Skin Cooler Roller - LARGE (green)SCRLARGEGREENBX012025-03-04
00850064466355Skin Cooler PenSCPBX012025-03-02
00850064466362Skin Cooler Roller - SMALL (white)SCRSMALLWHITEBX012025-03-04
00850064466188Blunt Tip Microcannula Slim Fabinject 22G50MMBTC22G050BX102025-02-28
00850064466348VF1000LED Vein locatorVF1000LEDBX12025-03-02
00850064466249Duck-bill Tip Microcannula Slim Fabinject 15G100MMDBC15G100BX102024-08-14
00850064466256Duck-bill Tip Microcannula Slim Fabinject 20G70MMDBC20G070BX102024-08-14
00850064466034Blunt Tip Microcannula Slim Fabinject 20G100MMBTC20G100UOU2024-08-13
00850064466041Blunt Tip Microcannula Slim Fabinject 21G50MM BTC21G050UOU2024-08-13
00850064466058Blunt Tip Microcannula Slim Fabinject 21G70MMBTC21G070UOU2024-08-13
00850064466065Blunt Tip Microcannula Slim Fabinject 22G50MM BTC22G050UOU2024-08-13
00850064466072Blunt Tip Microcannula Slim Fabinject 22G70MMBTC22G070UOU2024-08-13
00850064466126Duck-bill Tip Microcannula Slim Fabinject 15G100MMDBC15G100UOU2024-08-13
00850064466133Duck-bill Tip Microcannula Slim Fabinject 20G70MM DBC20G070UOU2024-08-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
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08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
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08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14