FDA.reportPublic FDA data

Skin Cooler Roller - LARGE (white)

Primary DI
00850064466409
Brand
Skin Cooler Roller - LARGE (white)
Company
FABINJECT LLC
Model
SCRLARGEWHITEBX01
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
00850064466409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064466409008500644664098500644664090850064466409

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
00850064466379Skin Cooler Roller - SMALL (lilac)SCRSMALLLILACBX012025-03-04
00850064466386Skin Cooler Roller - SMALL (blue)SCRSMALLBLUEBX012025-03-04
00850064466393Skin Cooler Roller - SMALL (green)SCRSMALLGREENBX012025-03-04
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
00850064466027FREDDO056/24-32102024-10-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840295411637TherabodyTherabody, Inc.IME2026-06-01
05056387401836Silvalea Boned Back Stand aid poly loops LARGESILVALEA LIMITEDINE2025-03-13
05056387401850Silvalea Boned Back Stand aid poly loops MEDIUMSILVALEA LIMITEDINE2025-03-13
05056387401898Silvalea Boned Back Stand aid poly loops EXTRA LARGESILVALEA LIMITEDINE2025-03-13
05056387439426Rachel Harness Mesh Navy XXXSmallSILVALEA LIMITEDINE2024-08-05
05056387439433Rachel Harness Mesh Navy XXSmallSILVALEA LIMITEDINE2024-08-05
05056387439440Rachel Harness Mesh Navy Extra SmallSILVALEA LIMITEDINE2024-08-05
05056387439457Rachel Harness Mesh Navy SmallSILVALEA LIMITEDINE2024-08-05
05056387439464Rachel Harness Mesh Navy MediumSILVALEA LIMITEDINE2024-08-05
05056387439471Rachel Harness Mesh Navy LargeSILVALEA LIMITEDINE2024-08-05
05056387438900In-Situ Repositioning Sheet MediumSILVALEA LIMITEDINE2024-07-29
05056387438917In-Situ Repositioning Sheet LargeSILVALEA LIMITEDINE2024-07-29
05056387438924In-Situ Repositioning Sheet Extra LargeSILVALEA LIMITEDINE2024-07-29
05056387439372Stretcher Sling Mesh SmallSILVALEA LIMITEDINE2024-07-29
05056387439389Stretcher Sling Mesh MediumSILVALEA LIMITEDINE2024-07-29
05056387439396Stretcher Sling Mesh LargeSILVALEA LIMITEDINE2024-07-29
05056387439402Stretcher Sling Mesh Extra LargeSILVALEA LIMITEDINE2024-07-29
05056387415864Disposable High Easy LOOPS LargeSILVALEA LIMITEDINE2024-03-11
05056387415871Disposable High Easy Poly LOOPS LargeSILVALEA LIMITEDINE2024-03-11
05056387415888Disposable High Easy LOOPS MEDIUMSILVALEA LIMITEDINE2024-03-11
05056387415895Disposable High Easy Poly LOOPS MediumSILVALEA LIMITEDINE2024-03-11
05056387415901Disposable High Easy LOOPS SmallSILVALEA LIMITEDINE2024-03-11
05056387415918Disposable High Easy LOOPS Extra LargeSILVALEA LIMITEDINE2024-03-11
05056387415925Disposable High Easy LOOPS Extra SmallSILVALEA LIMITEDINE2024-03-11
05056387415932Disposable High Easy LOOPS XXLargeSILVALEA LIMITEDINE2024-03-11
05056387437040Repositioning Sheet Close Weave PolyesterSILVALEA LIMITEDINE2024-02-29
05056387403823General Stand Aid Sling D-A Clips White Extra LargeSILVALEA LIMITEDINE2024-02-28
05056387405148Birthing Sling ManualSILVALEA LIMITEDINE2024-02-28
05056387409245Stand Up Sling Clip Fixings LargeSILVALEA LIMITEDINE2024-02-28
05056387409252Stand Up Sling Loop Fixings LargeSILVALEA LIMITEDINE2024-02-28