FDA.reportPublic FDA data

Skin Cooler Roller - SMALL (green)

Primary DI
00850064466393
Brand
Skin Cooler Roller - SMALL (green)
Company
FABINJECT LLC
Model
SCRSMALLGREENBX01
Device description
Local cooling device for therapeutic procedures.
Published
2025-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable
INESling, Overhead Suspension, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064466393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064466393008500644663938500644663930850064466393

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, reusableA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+55123021415loja@fabinject.com.br
+1(321) 972-4528contact@fabinject.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850064466027FREDDO120 v2024-10-28
00850064466379Skin Cooler Roller - SMALL (lilac)SCRSMALLLILACBX012025-03-04
00850064466386Skin Cooler Roller - SMALL (blue)SCRSMALLBLUEBX012025-03-04
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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