FDA.reportPublic FDA data

FREDDO

Primary DI
00850064466027
Brand
FREDDO
Company
FABINJECT LLC
Model
120 v
Device description
Skin cooling device
Published
2024-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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 Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
032329574
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
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08800291820200DermaVCynosure Lutronic Technology CorporationGEX2026-06-23
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08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
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