COMPRESS, INSTANT COLD GEL PACK 6" x 8"


Product Overview

COMPRESS, INSTANT COLD GEL PACK 6" x 8"
Cypress - 97-04


Device Description

A 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, peat) 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 single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: IME

Device Name: Pack, Hot Or Cold, Reusable

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: PM

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 890.5700

Third Party Flag: N

Medical Specialty: PM


Device Identifiers

Device Id: 00815555024155

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00815555024148

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case


Device Id: 00815555024148

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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