- Physicians Office Resource

PREVI ISOLA APPLICATORS CARTRIDGE
PREVI™ Isola Applicator Cartrige - PREVI™ Isola Applicator Cartrige

Device Description

A component of an automated/semi-automated in vitro diagnostic laboratory analyser or instrument intended to be used onboard to collect, transfer and spread an inoculum from a clinical specimen and/or culture isolate onto/into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It is typically made of sterilizable materials (e.g., plastic, metal) and consists of a shaft with a loop, wand, or swab at one or both ends. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LXG

Device Name: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.2050

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 03573026219680

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 03573026613112

Package Quantity: 8

Package Discontinue Date: 12/31/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 03573026613112

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

Device Id: 03573026612863

Device Type: Unit of Use

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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