Skin Cooler Roller - SMALL (blue)

GUDID 07898493080134

Local cooling device for therapeutic procedures.

FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA

Hot/cold therapy pack, reusable
Primary Device ID07898493080134
NIH Device Record Keyb940d8b6-8689-4708-a123-438adf53c6af
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkin Cooler Roller - SMALL (blue)
Version Model NumberSCRSMALLBLUEBX01
Company DUNS902645407
Company NameFABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br
Phone+551236021415
Emailloja@fabinject.com.br

Device Identifiers

Device Issuing AgencyDevice ID
GS107898493080134 [Primary]

FDA Product Code

IMEPack, Hot Or Cold, Reusable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-03-03
Device Publish Date2024-06-14

On-Brand Devices [Skin Cooler Roller - SMALL (blue)]

00850064466386Local cooling device for therapeutic procedures.
07898493080134Local cooling device for therapeutic procedures.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.