Skin Cooler Roller - LARGE (blue)

GUDID 07898493080097

Local cooling device for therapeutic procedures.

FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA

Hot/cold therapy pack, reusable

• Primary Device ID: 07898493080097
• NIH Device Record Key: 07a54815-5555-4973-9765-088cd6fa9b7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skin Cooler Roller - LARGE (blue)
• Version Model Number: SCRLARGEBLUEBX01
• Company DUNS: 902645407
• Company Name: FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br
• Phone: +55123021415
• Email: loja@fabinject.com.br

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898493080097 [Primary]

FDA Product Code

• INE: Sling, Overhead Suspension, Wheelchair

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-03-03
• Device Publish Date: 2024-06-14

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

• 00850064466423: Local cooling device for therapeutic procedures.
• 07898493080097: Local cooling device for therapeutic procedures.